experimental design for treatment

• Privacy Policy

Home » Experimental Design – Types, Methods, Guide

Experimental Design – Types, Methods, Guide

Table of Contents

Experimental Design

Experimental design is a process of planning and conducting scientific experiments to investigate a hypothesis or research question. It involves carefully designing an experiment that can test the hypothesis, and controlling for other variables that may influence the results.

Experimental design typically includes identifying the variables that will be manipulated or measured, defining the sample or population to be studied, selecting an appropriate method of sampling, choosing a method for data collection and analysis, and determining the appropriate statistical tests to use.

Types of Experimental Design

Here are the different types of experimental design:

Completely Randomized Design

In this design, participants are randomly assigned to one of two or more groups, and each group is exposed to a different treatment or condition.

Randomized Block Design

This design involves dividing participants into blocks based on a specific characteristic, such as age or gender, and then randomly assigning participants within each block to one of two or more treatment groups.

Factorial Design

In a factorial design, participants are randomly assigned to one of several groups, each of which receives a different combination of two or more independent variables.

Repeated Measures Design

In this design, each participant is exposed to all of the different treatments or conditions, either in a random order or in a predetermined order.

Crossover Design

This design involves randomly assigning participants to one of two or more treatment groups, with each group receiving one treatment during the first phase of the study and then switching to a different treatment during the second phase.

Split-plot Design

In this design, the researcher manipulates one or more variables at different levels and uses a randomized block design to control for other variables.

Nested Design

This design involves grouping participants within larger units, such as schools or households, and then randomly assigning these units to different treatment groups.

Laboratory Experiment

Laboratory experiments are conducted under controlled conditions, which allows for greater precision and accuracy. However, because laboratory conditions are not always representative of real-world conditions, the results of these experiments may not be generalizable to the population at large.

Field Experiment

Field experiments are conducted in naturalistic settings and allow for more realistic observations. However, because field experiments are not as controlled as laboratory experiments, they may be subject to more sources of error.

Experimental Design Methods

Experimental design methods refer to the techniques and procedures used to design and conduct experiments in scientific research. Here are some common experimental design methods:

Randomization

This involves randomly assigning participants to different groups or treatments to ensure that any observed differences between groups are due to the treatment and not to other factors.

Control Group

The use of a control group is an important experimental design method that involves having a group of participants that do not receive the treatment or intervention being studied. The control group is used as a baseline to compare the effects of the treatment group.

Blinding involves keeping participants, researchers, or both unaware of which treatment group participants are in, in order to reduce the risk of bias in the results.

Counterbalancing

This involves systematically varying the order in which participants receive treatments or interventions in order to control for order effects.

Replication

Replication involves conducting the same experiment with different samples or under different conditions to increase the reliability and validity of the results.

This experimental design method involves manipulating multiple independent variables simultaneously to investigate their combined effects on the dependent variable.

This involves dividing participants into subgroups or blocks based on specific characteristics, such as age or gender, in order to reduce the risk of confounding variables.

Data Collection Method

Experimental design data collection methods are techniques and procedures used to collect data in experimental research. Here are some common experimental design data collection methods:

Direct Observation

This method involves observing and recording the behavior or phenomenon of interest in real time. It may involve the use of structured or unstructured observation, and may be conducted in a laboratory or naturalistic setting.

Self-report Measures

Self-report measures involve asking participants to report their thoughts, feelings, or behaviors using questionnaires, surveys, or interviews. These measures may be administered in person or online.

Behavioral Measures

Behavioral measures involve measuring participants’ behavior directly, such as through reaction time tasks or performance tests. These measures may be administered using specialized equipment or software.

Physiological Measures

Physiological measures involve measuring participants’ physiological responses, such as heart rate, blood pressure, or brain activity, using specialized equipment. These measures may be invasive or non-invasive, and may be administered in a laboratory or clinical setting.

Archival Data

Archival data involves using existing records or data, such as medical records, administrative records, or historical documents, as a source of information. These data may be collected from public or private sources.

Computerized Measures

Computerized measures involve using software or computer programs to collect data on participants’ behavior or responses. These measures may include reaction time tasks, cognitive tests, or other types of computer-based assessments.

Video Recording

Video recording involves recording participants’ behavior or interactions using cameras or other recording equipment. This method can be used to capture detailed information about participants’ behavior or to analyze social interactions.

Data Analysis Method

Experimental design data analysis methods refer to the statistical techniques and procedures used to analyze data collected in experimental research. Here are some common experimental design data analysis methods:

Descriptive Statistics

Descriptive statistics are used to summarize and describe the data collected in the study. This includes measures such as mean, median, mode, range, and standard deviation.

Inferential Statistics

Inferential statistics are used to make inferences or generalizations about a larger population based on the data collected in the study. This includes hypothesis testing and estimation.

Analysis of Variance (ANOVA)

ANOVA is a statistical technique used to compare means across two or more groups in order to determine whether there are significant differences between the groups. There are several types of ANOVA, including one-way ANOVA, two-way ANOVA, and repeated measures ANOVA.

Regression Analysis

Regression analysis is used to model the relationship between two or more variables in order to determine the strength and direction of the relationship. There are several types of regression analysis, including linear regression, logistic regression, and multiple regression.

Factor Analysis

Factor analysis is used to identify underlying factors or dimensions in a set of variables. This can be used to reduce the complexity of the data and identify patterns in the data.

Structural Equation Modeling (SEM)

SEM is a statistical technique used to model complex relationships between variables. It can be used to test complex theories and models of causality.

Cluster Analysis

Cluster analysis is used to group similar cases or observations together based on similarities or differences in their characteristics.

Time Series Analysis

Time series analysis is used to analyze data collected over time in order to identify trends, patterns, or changes in the data.

Multilevel Modeling

Multilevel modeling is used to analyze data that is nested within multiple levels, such as students nested within schools or employees nested within companies.

Applications of Experimental Design 

Experimental design is a versatile research methodology that can be applied in many fields. Here are some applications of experimental design:

• Medical Research: Experimental design is commonly used to test new treatments or medications for various medical conditions. This includes clinical trials to evaluate the safety and effectiveness of new drugs or medical devices.
• Agriculture : Experimental design is used to test new crop varieties, fertilizers, and other agricultural practices. This includes randomized field trials to evaluate the effects of different treatments on crop yield, quality, and pest resistance.
• Environmental science: Experimental design is used to study the effects of environmental factors, such as pollution or climate change, on ecosystems and wildlife. This includes controlled experiments to study the effects of pollutants on plant growth or animal behavior.
• Psychology : Experimental design is used to study human behavior and cognitive processes. This includes experiments to test the effects of different interventions, such as therapy or medication, on mental health outcomes.
• Engineering : Experimental design is used to test new materials, designs, and manufacturing processes in engineering applications. This includes laboratory experiments to test the strength and durability of new materials, or field experiments to test the performance of new technologies.
• Education : Experimental design is used to evaluate the effectiveness of teaching methods, educational interventions, and programs. This includes randomized controlled trials to compare different teaching methods or evaluate the impact of educational programs on student outcomes.
• Marketing : Experimental design is used to test the effectiveness of marketing campaigns, pricing strategies, and product designs. This includes experiments to test the impact of different marketing messages or pricing schemes on consumer behavior.

Examples of Experimental Design 

Here are some examples of experimental design in different fields:

• Example in Medical research : A study that investigates the effectiveness of a new drug treatment for a particular condition. Patients are randomly assigned to either a treatment group or a control group, with the treatment group receiving the new drug and the control group receiving a placebo. The outcomes, such as improvement in symptoms or side effects, are measured and compared between the two groups.
• Example in Education research: A study that examines the impact of a new teaching method on student learning outcomes. Students are randomly assigned to either a group that receives the new teaching method or a group that receives the traditional teaching method. Student achievement is measured before and after the intervention, and the results are compared between the two groups.
• Example in Environmental science: A study that tests the effectiveness of a new method for reducing pollution in a river. Two sections of the river are selected, with one section treated with the new method and the other section left untreated. The water quality is measured before and after the intervention, and the results are compared between the two sections.
• Example in Marketing research: A study that investigates the impact of a new advertising campaign on consumer behavior. Participants are randomly assigned to either a group that is exposed to the new campaign or a group that is not. Their behavior, such as purchasing or product awareness, is measured and compared between the two groups.
• Example in Social psychology: A study that examines the effect of a new social intervention on reducing prejudice towards a marginalized group. Participants are randomly assigned to either a group that receives the intervention or a control group that does not. Their attitudes and behavior towards the marginalized group are measured before and after the intervention, and the results are compared between the two groups.

When to use Experimental Research Design 

Experimental research design should be used when a researcher wants to establish a cause-and-effect relationship between variables. It is particularly useful when studying the impact of an intervention or treatment on a particular outcome.

Here are some situations where experimental research design may be appropriate:

• When studying the effects of a new drug or medical treatment: Experimental research design is commonly used in medical research to test the effectiveness and safety of new drugs or medical treatments. By randomly assigning patients to treatment and control groups, researchers can determine whether the treatment is effective in improving health outcomes.
• When evaluating the effectiveness of an educational intervention: An experimental research design can be used to evaluate the impact of a new teaching method or educational program on student learning outcomes. By randomly assigning students to treatment and control groups, researchers can determine whether the intervention is effective in improving academic performance.
• When testing the effectiveness of a marketing campaign: An experimental research design can be used to test the effectiveness of different marketing messages or strategies. By randomly assigning participants to treatment and control groups, researchers can determine whether the marketing campaign is effective in changing consumer behavior.
• When studying the effects of an environmental intervention: Experimental research design can be used to study the impact of environmental interventions, such as pollution reduction programs or conservation efforts. By randomly assigning locations or areas to treatment and control groups, researchers can determine whether the intervention is effective in improving environmental outcomes.
• When testing the effects of a new technology: An experimental research design can be used to test the effectiveness and safety of new technologies or engineering designs. By randomly assigning participants or locations to treatment and control groups, researchers can determine whether the new technology is effective in achieving its intended purpose.

How to Conduct Experimental Research

Here are the steps to conduct Experimental Research:

• Identify a Research Question : Start by identifying a research question that you want to answer through the experiment. The question should be clear, specific, and testable.
• Develop a Hypothesis: Based on your research question, develop a hypothesis that predicts the relationship between the independent and dependent variables. The hypothesis should be clear and testable.
• Design the Experiment : Determine the type of experimental design you will use, such as a between-subjects design or a within-subjects design. Also, decide on the experimental conditions, such as the number of independent variables, the levels of the independent variable, and the dependent variable to be measured.
• Select Participants: Select the participants who will take part in the experiment. They should be representative of the population you are interested in studying.
• Randomly Assign Participants to Groups: If you are using a between-subjects design, randomly assign participants to groups to control for individual differences.
• Conduct the Experiment : Conduct the experiment by manipulating the independent variable(s) and measuring the dependent variable(s) across the different conditions.
• Analyze the Data: Analyze the data using appropriate statistical methods to determine if there is a significant effect of the independent variable(s) on the dependent variable(s).
• Draw Conclusions: Based on the data analysis, draw conclusions about the relationship between the independent and dependent variables. If the results support the hypothesis, then it is accepted. If the results do not support the hypothesis, then it is rejected.
• Communicate the Results: Finally, communicate the results of the experiment through a research report or presentation. Include the purpose of the study, the methods used, the results obtained, and the conclusions drawn.

Purpose of Experimental Design 

The purpose of experimental design is to control and manipulate one or more independent variables to determine their effect on a dependent variable. Experimental design allows researchers to systematically investigate causal relationships between variables, and to establish cause-and-effect relationships between the independent and dependent variables. Through experimental design, researchers can test hypotheses and make inferences about the population from which the sample was drawn.

Experimental design provides a structured approach to designing and conducting experiments, ensuring that the results are reliable and valid. By carefully controlling for extraneous variables that may affect the outcome of the study, experimental design allows researchers to isolate the effect of the independent variable(s) on the dependent variable(s), and to minimize the influence of other factors that may confound the results.

Experimental design also allows researchers to generalize their findings to the larger population from which the sample was drawn. By randomly selecting participants and using statistical techniques to analyze the data, researchers can make inferences about the larger population with a high degree of confidence.

Overall, the purpose of experimental design is to provide a rigorous, systematic, and scientific method for testing hypotheses and establishing cause-and-effect relationships between variables. Experimental design is a powerful tool for advancing scientific knowledge and informing evidence-based practice in various fields, including psychology, biology, medicine, engineering, and social sciences.

Advantages of Experimental Design 

Experimental design offers several advantages in research. Here are some of the main advantages:

• Control over extraneous variables: Experimental design allows researchers to control for extraneous variables that may affect the outcome of the study. By manipulating the independent variable and holding all other variables constant, researchers can isolate the effect of the independent variable on the dependent variable.
• Establishing causality: Experimental design allows researchers to establish causality by manipulating the independent variable and observing its effect on the dependent variable. This allows researchers to determine whether changes in the independent variable cause changes in the dependent variable.
• Replication : Experimental design allows researchers to replicate their experiments to ensure that the findings are consistent and reliable. Replication is important for establishing the validity and generalizability of the findings.
• Random assignment: Experimental design often involves randomly assigning participants to conditions. This helps to ensure that individual differences between participants are evenly distributed across conditions, which increases the internal validity of the study.
• Precision : Experimental design allows researchers to measure variables with precision, which can increase the accuracy and reliability of the data.
• Generalizability : If the study is well-designed, experimental design can increase the generalizability of the findings. By controlling for extraneous variables and using random assignment, researchers can increase the likelihood that the findings will apply to other populations and contexts.

Limitations of Experimental Design

Experimental design has some limitations that researchers should be aware of. Here are some of the main limitations:

• Artificiality : Experimental design often involves creating artificial situations that may not reflect real-world situations. This can limit the external validity of the findings, or the extent to which the findings can be generalized to real-world settings.
• Ethical concerns: Some experimental designs may raise ethical concerns, particularly if they involve manipulating variables that could cause harm to participants or if they involve deception.
• Participant bias : Participants in experimental studies may modify their behavior in response to the experiment, which can lead to participant bias.
• Limited generalizability: The conditions of the experiment may not reflect the complexities of real-world situations. As a result, the findings may not be applicable to all populations and contexts.
• Cost and time : Experimental design can be expensive and time-consuming, particularly if the experiment requires specialized equipment or if the sample size is large.
• Researcher bias : Researchers may unintentionally bias the results of the experiment if they have expectations or preferences for certain outcomes.
• Lack of feasibility : Experimental design may not be feasible in some cases, particularly if the research question involves variables that cannot be manipulated or controlled.

About the author

Muhammad Hassan

Researcher, Academic Writer, Web developer

You may also like

Focus Groups – Steps, Examples and Guide

Transformative Design – Methods, Types, Guide

Exploratory Research – Types, Methods and...

Survey Research – Types, Methods, Examples

Applied Research – Types, Methods and Examples

Phenomenology – Methods, Examples and Guide

• Skip to secondary menu
• Skip to main content
• Skip to primary sidebar

Statistics By Jim

Making statistics intuitive

Experimental Design: Definition and Types

By Jim Frost 3 Comments

What is Experimental Design?

An experimental design is a detailed plan for collecting and using data to identify causal relationships. Through careful planning, the design of experiments allows your data collection efforts to have a reasonable chance of detecting effects and testing hypotheses that answer your research questions.

An experiment is a data collection procedure that occurs in controlled conditions to identify and understand causal relationships between variables. Researchers can use many potential designs. The ultimate choice depends on their research question, resources, goals, and constraints. In some fields of study, researchers refer to experimental design as the design of experiments (DOE). Both terms are synonymous.

Ultimately, the design of experiments helps ensure that your procedures and data will evaluate your research question effectively. Without an experimental design, you might waste your efforts in a process that, for many potential reasons, can’t answer your research question. In short, it helps you trust your results.

Learn more about Independent and Dependent Variables .

Design of Experiments: Goals & Settings

Experiments occur in many settings, ranging from psychology, social sciences, medicine, physics, engineering, and industrial and service sectors. Typically, experimental goals are to discover a previously unknown effect , confirm a known effect, or test a hypothesis.

Effects represent causal relationships between variables. For example, in a medical experiment, does the new medicine cause an improvement in health outcomes? If so, the medicine has a causal effect on the outcome.

An experimental design’s focus depends on the subject area and can include the following goals:

• Understanding the relationships between variables.
• Identifying the variables that have the largest impact on the outcomes.
• Finding the input variable settings that produce an optimal result.

For example, psychologists have conducted experiments to understand how conformity affects decision-making. Sociologists have performed experiments to determine whether ethnicity affects the public reaction to staged bike thefts. These experiments map out the causal relationships between variables, and their primary goal is to understand the role of various factors.

Conversely, in a manufacturing environment, the researchers might use an experimental design to find the factors that most effectively improve their product’s strength, identify the optimal manufacturing settings, and do all that while accounting for various constraints. In short, a manufacturer’s goal is often to use experiments to improve their products cost-effectively.

In a medical experiment, the goal might be to quantify the medicine’s effect and find the optimum dosage.

Developing an Experimental Design

Developing an experimental design involves planning that maximizes the potential to collect data that is both trustworthy and able to detect causal relationships. Specifically, these studies aim to see effects when they exist in the population the researchers are studying, preferentially favor causal effects, isolate each factor’s true effect from potential confounders, and produce conclusions that you can generalize to the real world.

To accomplish these goals, experimental designs carefully manage data validity and reliability , and internal and external experimental validity. When your experiment is valid and reliable, you can expect your procedures and data to produce trustworthy results.

An excellent experimental design involves the following:

• Lots of preplanning.
• Developing experimental treatments.
• Determining how to assign subjects to treatment groups.

The remainder of this article focuses on how experimental designs incorporate these essential items to accomplish their research goals.

Learn more about Data Reliability vs. Validity and Internal and External Experimental Validity .

Preplanning, Defining, and Operationalizing for Design of Experiments

This phase of the design of experiments helps you identify critical variables, know how to measure them while ensuring reliability and validity, and understand the relationships between them. The review can also help you find ways to reduce sources of variability, which increases your ability to detect treatment effects. Notably, the literature review allows you to learn how similar studies designed their experiments and the challenges they faced.

Operationalizing a study involves taking your research question, using the background information you gathered, and formulating an actionable plan.

This process should produce a specific and testable hypothesis using data that you can reasonably collect given the resources available to the experiment.

• Null hypothesis : The jumping exercise intervention does not affect bone density.
• Alternative hypothesis : The jumping exercise intervention affects bone density.

To learn more about this early phase, read Five Steps for Conducting Scientific Studies with Statistical Analyses .

Formulating Treatments in Experimental Designs

In an experimental design, treatments are variables that the researchers control. They are the primary independent variables of interest. Researchers administer the treatment to the subjects or items in the experiment and want to know whether it causes changes in the outcome.

As the name implies, a treatment can be medical in nature, such as a new medicine or vaccine. But it’s a general term that applies to other things such as training programs, manufacturing settings, teaching methods, and types of fertilizers. I helped run an experiment where the treatment was a jumping exercise intervention that we hoped would increase bone density. All these treatment examples are things that potentially influence a measurable outcome.

Even when you know your treatment generally, you must carefully consider the amount. How large of a dose? If you’re comparing three different temperatures in a manufacturing process, how far apart are they? For my bone mineral density study, we had to determine how frequently the exercise sessions would occur and how long each lasted.

How you define the treatments in the design of experiments can affect your findings and the generalizability of your results.

Assigning Subjects to Experimental Groups

A crucial decision for all experimental designs is determining how researchers assign subjects to the experimental conditions—the treatment and control groups. The control group is often, but not always, the lack of a treatment. It serves as a basis for comparison by showing outcomes for subjects who don’t receive a treatment. Learn more about Control Groups .

How your experimental design assigns subjects to the groups affects how confident you can be that the findings represent true causal effects rather than mere correlation caused by confounders. Indeed, the assignment method influences how you control for confounding variables. This is the difference between correlation and causation .

Imagine a study finds that vitamin consumption correlates with better health outcomes. As a researcher, you want to be able to say that vitamin consumption causes the improvements. However, with the wrong experimental design, you might only be able to say there is an association. A confounder, and not the vitamins, might actually cause the health benefits.

Let’s explore some of the ways to assign subjects in design of experiments.

Completely Randomized Designs

A completely randomized experimental design randomly assigns all subjects to the treatment and control groups. You simply take each participant and use a random process to determine their group assignment. You can flip coins, roll a die, or use a computer. Randomized experiments must be prospective studies because they need to be able to control group assignment.

Random assignment in the design of experiments helps ensure that the groups are roughly equivalent at the beginning of the study. This equivalence at the start increases your confidence that any differences you see at the end were caused by the treatments. The randomization tends to equalize confounders between the experimental groups and, thereby, cancels out their effects, leaving only the treatment effects.

For example, in a vitamin study, the researchers can randomly assign participants to either the control or vitamin group. Because the groups are approximately equal when the experiment starts, if the health outcomes are different at the end of the study, the researchers can be confident that the vitamins caused those improvements.

Statisticians consider randomized experimental designs to be the best for identifying causal relationships.

If you can’t randomly assign subjects but want to draw causal conclusions about an intervention, consider using a quasi-experimental design .

Learn more about Randomized Controlled Trials and Random Assignment in Experiments .

Randomized Block Designs

Nuisance factors are variables that can affect the outcome, but they are not the researcher’s primary interest. Unfortunately, they can hide or distort the treatment results. When experimenters know about specific nuisance factors, they can use a randomized block design to minimize their impact.

This experimental design takes subjects with a shared “nuisance” characteristic and groups them into blocks. The participants in each block are then randomly assigned to the experimental groups. This process allows the experiment to control for known nuisance factors.

Blocking in the design of experiments reduces the impact of nuisance factors on experimental error. The analysis assesses the effects of the treatment within each block, which removes the variability between blocks. The result is that blocked experimental designs can reduce the impact of nuisance variables, increasing the ability to detect treatment effects accurately.

Suppose you’re testing various teaching methods. Because grade level likely affects educational outcomes, you might use grade level as a blocking factor. To use a randomized block design for this scenario, divide the participants by grade level and then randomly assign the members of each grade level to the experimental groups.

A standard guideline for an experimental design is to “Block what you can, randomize what you cannot.” Use blocking for a few primary nuisance factors. Then use random assignment to distribute the unblocked nuisance factors equally between the experimental conditions.

You can also use covariates to control nuisance factors. Learn about Covariates: Definition and Uses .

Observational Studies

In some experimental designs, randomly assigning subjects to the experimental conditions is impossible or unethical. The researchers simply can’t assign participants to the experimental groups. However, they can observe them in their natural groupings, measure the essential variables, and look for correlations. These observational studies are also known as quasi-experimental designs. Retrospective studies must be observational in nature because they look back at past events.

Imagine you’re studying the effects of depression on an activity. Clearly, you can’t randomly assign participants to the depression and control groups. But you can observe participants with and without depression and see how their task performance differs.

Observational studies let you perform research when you can’t control the treatment. However, quasi-experimental designs increase the problem of confounding variables. For this design of experiments, correlation does not necessarily imply causation. While special procedures can help control confounders in an observational study, you’re ultimately less confident that the results represent causal findings.

Learn more about Observational Studies .

For a good comparison, learn about the differences and tradeoffs between Observational Studies and Randomized Experiments .

Between-Subjects vs. Within-Subjects Experimental Designs

When you think of the design of experiments, you probably picture a treatment and control group. Researchers assign participants to only one of these groups, so each group contains entirely different subjects than the other groups. Analysts compare the groups at the end of the experiment. Statisticians refer to this method as a between-subjects, or independent measures, experimental design.

In a between-subjects design , you can have more than one treatment group, but each subject is exposed to only one condition, the control group or one of the treatment groups.

A potential downside to this approach is that differences between groups at the beginning can affect the results at the end. As you’ve read earlier, random assignment can reduce those differences, but it is imperfect. There will always be some variability between the groups.

In a  within-subjects experimental design , also known as repeated measures, subjects experience all treatment conditions and are measured for each. Each subject acts as their own control, which reduces variability and increases the statistical power to detect effects.

In this experimental design, you minimize pre-existing differences between the experimental conditions because they all contain the same subjects. However, the order of treatments can affect the results. Beware of practice and fatigue effects. Learn more about Repeated Measures Designs .

Design of Experiments Examples

For example, a bone density study has three experimental groups—a control group, a stretching exercise group, and a jumping exercise group.

In a between-subjects experimental design, scientists randomly assign each participant to one of the three groups.

In a within-subjects design, all subjects experience the three conditions sequentially while the researchers measure bone density repeatedly. The procedure can switch the order of treatments for the participants to help reduce order effects.

Matched Pairs Experimental Design

A matched pairs experimental design is a between-subjects study that uses pairs of similar subjects. Researchers use this approach to reduce pre-existing differences between experimental groups. It’s yet another design of experiments method for reducing sources of variability.

Researchers identify variables likely to affect the outcome, such as demographics. When they pick a subject with a set of characteristics, they try to locate another participant with similar attributes to create a matched pair. Scientists randomly assign one member of a pair to the treatment group and the other to the control group.

On the plus side, this process creates two similar groups, and it doesn’t create treatment order effects. While matched pairs do not produce the perfectly matched groups of a within-subjects design (which uses the same subjects in all conditions), it aims to reduce variability between groups relative to a between-subjects study.

On the downside, finding matched pairs is very time-consuming. Additionally, if one member of a matched pair drops out, the other subject must leave the study too.

Learn more about Matched Pairs Design: Uses & Examples .

Another consideration is whether you’ll use a cross-sectional design (one point in time) or use a longitudinal study to track changes over time .

A case study is a research method that often serves as a precursor to a more rigorous experimental design by identifying research questions, variables, and hypotheses to test. Learn more about What is a Case Study? Definition & Examples .

In conclusion, the design of experiments is extremely sensitive to subject area concerns and the time and resources available to the researchers. Developing a suitable experimental design requires balancing a multitude of considerations. A successful design is necessary to obtain trustworthy answers to your research question and to have a reasonable chance of detecting treatment effects when they exist.

Share this:

Reader Interactions

March 23, 2024 at 2:35 pm

Dear Jim You wrote a superb document, I will use it in my Buistatistics course, along with your three books. Thank you very much! Miguel

March 23, 2024 at 5:43 pm

Thanks so much, Miguel! Glad this post was helpful and I trust the books will be as well.

April 10, 2023 at 4:36 am

What are the purpose and uses of experimental research design?

Comments and Questions Cancel reply

Have a language expert improve your writing

Run a free plagiarism check in 10 minutes, automatically generate references for free.

• Knowledge Base
• Methodology
• A Quick Guide to Experimental Design | 5 Steps & Examples

A Quick Guide to Experimental Design | 5 Steps & Examples

Published on 11 April 2022 by Rebecca Bevans . Revised on 5 December 2022.

Experiments are used to study causal relationships . You manipulate one or more independent variables and measure their effect on one or more dependent variables.

Experimental design means creating a set of procedures to systematically test a hypothesis . A good experimental design requires a strong understanding of the system you are studying. 

There are five key steps in designing an experiment:

• Consider your variables and how they are related
• Write a specific, testable hypothesis
• Design experimental treatments to manipulate your independent variable
• Assign subjects to groups, either between-subjects or within-subjects
• Plan how you will measure your dependent variable

For valid conclusions, you also need to select a representative sample and control any  extraneous variables that might influence your results. If if random assignment of participants to control and treatment groups is impossible, unethical, or highly difficult, consider an observational study instead.

Table of contents

Step 1: define your variables, step 2: write your hypothesis, step 3: design your experimental treatments, step 4: assign your subjects to treatment groups, step 5: measure your dependent variable, frequently asked questions about experimental design.

You should begin with a specific research question . We will work with two research question examples, one from health sciences and one from ecology:

To translate your research question into an experimental hypothesis, you need to define the main variables and make predictions about how they are related.

Start by simply listing the independent and dependent variables .

Then you need to think about possible extraneous and confounding variables and consider how you might control  them in your experiment.

Finally, you can put these variables together into a diagram. Use arrows to show the possible relationships between variables and include signs to show the expected direction of the relationships.

Here we predict that increasing temperature will increase soil respiration and decrease soil moisture, while decreasing soil moisture will lead to decreased soil respiration.

Prevent plagiarism, run a free check.

Now that you have a strong conceptual understanding of the system you are studying, you should be able to write a specific, testable hypothesis that addresses your research question.

The next steps will describe how to design a controlled experiment . In a controlled experiment, you must be able to:

• Systematically and precisely manipulate the independent variable(s).
• Precisely measure the dependent variable(s).
• Control any potential confounding variables.

If your study system doesn’t match these criteria, there are other types of research you can use to answer your research question.

How you manipulate the independent variable can affect the experiment’s external validity – that is, the extent to which the results can be generalised and applied to the broader world.

First, you may need to decide how widely to vary your independent variable.

• just slightly above the natural range for your study region.
• over a wider range of temperatures to mimic future warming.
• over an extreme range that is beyond any possible natural variation.

Second, you may need to choose how finely to vary your independent variable. Sometimes this choice is made for you by your experimental system, but often you will need to decide, and this will affect how much you can infer from your results.

• a categorical variable : either as binary (yes/no) or as levels of a factor (no phone use, low phone use, high phone use).
• a continuous variable (minutes of phone use measured every night).

How you apply your experimental treatments to your test subjects is crucial for obtaining valid and reliable results.

First, you need to consider the study size : how many individuals will be included in the experiment? In general, the more subjects you include, the greater your experiment’s statistical power , which determines how much confidence you can have in your results.

Then you need to randomly assign your subjects to treatment groups . Each group receives a different level of the treatment (e.g. no phone use, low phone use, high phone use).

You should also include a control group , which receives no treatment. The control group tells us what would have happened to your test subjects without any experimental intervention.

When assigning your subjects to groups, there are two main choices you need to make:

• A completely randomised design vs a randomised block design .
• A between-subjects design vs a within-subjects design .

Randomisation

An experiment can be completely randomised or randomised within blocks (aka strata):

• In a completely randomised design , every subject is assigned to a treatment group at random.
• In a randomised block design (aka stratified random design), subjects are first grouped according to a characteristic they share, and then randomly assigned to treatments within those groups.

Sometimes randomisation isn’t practical or ethical , so researchers create partially-random or even non-random designs. An experimental design where treatments aren’t randomly assigned is called a quasi-experimental design .

Between-subjects vs within-subjects

In a between-subjects design (also known as an independent measures design or classic ANOVA design), individuals receive only one of the possible levels of an experimental treatment.

In medical or social research, you might also use matched pairs within your between-subjects design to make sure that each treatment group contains the same variety of test subjects in the same proportions.

In a within-subjects design (also known as a repeated measures design), every individual receives each of the experimental treatments consecutively, and their responses to each treatment are measured.

Within-subjects or repeated measures can also refer to an experimental design where an effect emerges over time, and individual responses are measured over time in order to measure this effect as it emerges.

Counterbalancing (randomising or reversing the order of treatments among subjects) is often used in within-subjects designs to ensure that the order of treatment application doesn’t influence the results of the experiment.

Finally, you need to decide how you’ll collect data on your dependent variable outcomes. You should aim for reliable and valid measurements that minimise bias or error.

Some variables, like temperature, can be objectively measured with scientific instruments. Others may need to be operationalised to turn them into measurable observations.

• Ask participants to record what time they go to sleep and get up each day.
• Ask participants to wear a sleep tracker.

How precisely you measure your dependent variable also affects the kinds of statistical analysis you can use on your data.

Experiments are always context-dependent, and a good experimental design will take into account all of the unique considerations of your study system to produce information that is both valid and relevant to your research question.

Experimental designs are a set of procedures that you plan in order to examine the relationship between variables that interest you.

To design a successful experiment, first identify:

• A testable hypothesis
• One or more independent variables that you will manipulate
• One or more dependent variables that you will measure

When designing the experiment, first decide:

• How your variable(s) will be manipulated
• How you will control for any potential confounding or lurking variables
• How many subjects you will include
• How you will assign treatments to your subjects

The key difference between observational studies and experiments is that, done correctly, an observational study will never influence the responses or behaviours of participants. Experimental designs will have a treatment condition applied to at least a portion of participants.

A confounding variable , also called a confounder or confounding factor, is a third variable in a study examining a potential cause-and-effect relationship.

A confounding variable is related to both the supposed cause and the supposed effect of the study. It can be difficult to separate the true effect of the independent variable from the effect of the confounding variable.

In your research design , it’s important to identify potential confounding variables and plan how you will reduce their impact.

In a between-subjects design , every participant experiences only one condition, and researchers assess group differences between participants in various conditions.

In a within-subjects design , each participant experiences all conditions, and researchers test the same participants repeatedly for differences between conditions.

The word ‘between’ means that you’re comparing different conditions between groups, while the word ‘within’ means you’re comparing different conditions within the same group.

Cite this Scribbr article

If you want to cite this source, you can copy and paste the citation or click the ‘Cite this Scribbr article’ button to automatically add the citation to our free Reference Generator.

Bevans, R. (2022, December 05). A Quick Guide to Experimental Design | 5 Steps & Examples. Scribbr. Retrieved 9 September 2024, from https://www.scribbr.co.uk/research-methods/guide-to-experimental-design/

Is this article helpful?

Rebecca Bevans

Want to create or adapt books like this? Learn more about how Pressbooks supports open publishing practices.

6.2 Experimental Design

Learning objectives.

• Explain the difference between between-subjects and within-subjects experiments, list some of the pros and cons of each approach, and decide which approach to use to answer a particular research question.
• Define random assignment, distinguish it from random sampling, explain its purpose in experimental research, and use some simple strategies to implement it.
• Define what a control condition is, explain its purpose in research on treatment effectiveness, and describe some alternative types of control conditions.
• Define several types of carryover effect, give examples of each, and explain how counterbalancing helps to deal with them.

In this section, we look at some different ways to design an experiment. The primary distinction we will make is between approaches in which each participant experiences one level of the independent variable and approaches in which each participant experiences all levels of the independent variable. The former are called between-subjects experiments and the latter are called within-subjects experiments.

Between-Subjects Experiments

In a between-subjects experiment , each participant is tested in only one condition. For example, a researcher with a sample of 100 college students might assign half of them to write about a traumatic event and the other half write about a neutral event. Or a researcher with a sample of 60 people with severe agoraphobia (fear of open spaces) might assign 20 of them to receive each of three different treatments for that disorder. It is essential in a between-subjects experiment that the researcher assign participants to conditions so that the different groups are, on average, highly similar to each other. Those in a trauma condition and a neutral condition, for example, should include a similar proportion of men and women, and they should have similar average intelligence quotients (IQs), similar average levels of motivation, similar average numbers of health problems, and so on. This is a matter of controlling these extraneous participant variables across conditions so that they do not become confounding variables.

Random Assignment

The primary way that researchers accomplish this kind of control of extraneous variables across conditions is called random assignment , which means using a random process to decide which participants are tested in which conditions. Do not confuse random assignment with random sampling. Random sampling is a method for selecting a sample from a population, and it is rarely used in psychological research. Random assignment is a method for assigning participants in a sample to the different conditions, and it is an important element of all experimental research in psychology and other fields too.

In its strictest sense, random assignment should meet two criteria. One is that each participant has an equal chance of being assigned to each condition (e.g., a 50% chance of being assigned to each of two conditions). The second is that each participant is assigned to a condition independently of other participants. Thus one way to assign participants to two conditions would be to flip a coin for each one. If the coin lands heads, the participant is assigned to Condition A, and if it lands tails, the participant is assigned to Condition B. For three conditions, one could use a computer to generate a random integer from 1 to 3 for each participant. If the integer is 1, the participant is assigned to Condition A; if it is 2, the participant is assigned to Condition B; and if it is 3, the participant is assigned to Condition C. In practice, a full sequence of conditions—one for each participant expected to be in the experiment—is usually created ahead of time, and each new participant is assigned to the next condition in the sequence as he or she is tested. When the procedure is computerized, the computer program often handles the random assignment.

One problem with coin flipping and other strict procedures for random assignment is that they are likely to result in unequal sample sizes in the different conditions. Unequal sample sizes are generally not a serious problem, and you should never throw away data you have already collected to achieve equal sample sizes. However, for a fixed number of participants, it is statistically most efficient to divide them into equal-sized groups. It is standard practice, therefore, to use a kind of modified random assignment that keeps the number of participants in each group as similar as possible. One approach is block randomization . In block randomization, all the conditions occur once in the sequence before any of them is repeated. Then they all occur again before any of them is repeated again. Within each of these “blocks,” the conditions occur in a random order. Again, the sequence of conditions is usually generated before any participants are tested, and each new participant is assigned to the next condition in the sequence. Table 6.2 “Block Randomization Sequence for Assigning Nine Participants to Three Conditions” shows such a sequence for assigning nine participants to three conditions. The Research Randomizer website ( http://www.randomizer.org ) will generate block randomization sequences for any number of participants and conditions. Again, when the procedure is computerized, the computer program often handles the block randomization.

Table 6.2 Block Randomization Sequence for Assigning Nine Participants to Three Conditions

Random assignment is not guaranteed to control all extraneous variables across conditions. It is always possible that just by chance, the participants in one condition might turn out to be substantially older, less tired, more motivated, or less depressed on average than the participants in another condition. However, there are some reasons that this is not a major concern. One is that random assignment works better than one might expect, especially for large samples. Another is that the inferential statistics that researchers use to decide whether a difference between groups reflects a difference in the population takes the “fallibility” of random assignment into account. Yet another reason is that even if random assignment does result in a confounding variable and therefore produces misleading results, this is likely to be detected when the experiment is replicated. The upshot is that random assignment to conditions—although not infallible in terms of controlling extraneous variables—is always considered a strength of a research design.

Treatment and Control Conditions

Between-subjects experiments are often used to determine whether a treatment works. In psychological research, a treatment is any intervention meant to change people’s behavior for the better. This includes psychotherapies and medical treatments for psychological disorders but also interventions designed to improve learning, promote conservation, reduce prejudice, and so on. To determine whether a treatment works, participants are randomly assigned to either a treatment condition , in which they receive the treatment, or a control condition , in which they do not receive the treatment. If participants in the treatment condition end up better off than participants in the control condition—for example, they are less depressed, learn faster, conserve more, express less prejudice—then the researcher can conclude that the treatment works. In research on the effectiveness of psychotherapies and medical treatments, this type of experiment is often called a randomized clinical trial .

There are different types of control conditions. In a no-treatment control condition , participants receive no treatment whatsoever. One problem with this approach, however, is the existence of placebo effects. A placebo is a simulated treatment that lacks any active ingredient or element that should make it effective, and a placebo effect is a positive effect of such a treatment. Many folk remedies that seem to work—such as eating chicken soup for a cold or placing soap under the bedsheets to stop nighttime leg cramps—are probably nothing more than placebos. Although placebo effects are not well understood, they are probably driven primarily by people’s expectations that they will improve. Having the expectation to improve can result in reduced stress, anxiety, and depression, which can alter perceptions and even improve immune system functioning (Price, Finniss, & Benedetti, 2008).

Placebo effects are interesting in their own right (see Note 6.28 “The Powerful Placebo” ), but they also pose a serious problem for researchers who want to determine whether a treatment works. Figure 6.2 “Hypothetical Results From a Study Including Treatment, No-Treatment, and Placebo Conditions” shows some hypothetical results in which participants in a treatment condition improved more on average than participants in a no-treatment control condition. If these conditions (the two leftmost bars in Figure 6.2 “Hypothetical Results From a Study Including Treatment, No-Treatment, and Placebo Conditions” ) were the only conditions in this experiment, however, one could not conclude that the treatment worked. It could be instead that participants in the treatment group improved more because they expected to improve, while those in the no-treatment control condition did not.

Figure 6.2 Hypothetical Results From a Study Including Treatment, No-Treatment, and Placebo Conditions

Fortunately, there are several solutions to this problem. One is to include a placebo control condition , in which participants receive a placebo that looks much like the treatment but lacks the active ingredient or element thought to be responsible for the treatment’s effectiveness. When participants in a treatment condition take a pill, for example, then those in a placebo control condition would take an identical-looking pill that lacks the active ingredient in the treatment (a “sugar pill”). In research on psychotherapy effectiveness, the placebo might involve going to a psychotherapist and talking in an unstructured way about one’s problems. The idea is that if participants in both the treatment and the placebo control groups expect to improve, then any improvement in the treatment group over and above that in the placebo control group must have been caused by the treatment and not by participants’ expectations. This is what is shown by a comparison of the two outer bars in Figure 6.2 “Hypothetical Results From a Study Including Treatment, No-Treatment, and Placebo Conditions” .

Of course, the principle of informed consent requires that participants be told that they will be assigned to either a treatment or a placebo control condition—even though they cannot be told which until the experiment ends. In many cases the participants who had been in the control condition are then offered an opportunity to have the real treatment. An alternative approach is to use a waitlist control condition , in which participants are told that they will receive the treatment but must wait until the participants in the treatment condition have already received it. This allows researchers to compare participants who have received the treatment with participants who are not currently receiving it but who still expect to improve (eventually). A final solution to the problem of placebo effects is to leave out the control condition completely and compare any new treatment with the best available alternative treatment. For example, a new treatment for simple phobia could be compared with standard exposure therapy. Because participants in both conditions receive a treatment, their expectations about improvement should be similar. This approach also makes sense because once there is an effective treatment, the interesting question about a new treatment is not simply “Does it work?” but “Does it work better than what is already available?”

The Powerful Placebo

Many people are not surprised that placebos can have a positive effect on disorders that seem fundamentally psychological, including depression, anxiety, and insomnia. However, placebos can also have a positive effect on disorders that most people think of as fundamentally physiological. These include asthma, ulcers, and warts (Shapiro & Shapiro, 1999). There is even evidence that placebo surgery—also called “sham surgery”—can be as effective as actual surgery.

Medical researcher J. Bruce Moseley and his colleagues conducted a study on the effectiveness of two arthroscopic surgery procedures for osteoarthritis of the knee (Moseley et al., 2002). The control participants in this study were prepped for surgery, received a tranquilizer, and even received three small incisions in their knees. But they did not receive the actual arthroscopic surgical procedure. The surprising result was that all participants improved in terms of both knee pain and function, and the sham surgery group improved just as much as the treatment groups. According to the researchers, “This study provides strong evidence that arthroscopic lavage with or without débridement [the surgical procedures used] is not better than and appears to be equivalent to a placebo procedure in improving knee pain and self-reported function” (p. 85).

Research has shown that patients with osteoarthritis of the knee who receive a “sham surgery” experience reductions in pain and improvement in knee function similar to those of patients who receive a real surgery.

Army Medicine – Surgery – CC BY 2.0.

Within-Subjects Experiments

In a within-subjects experiment , each participant is tested under all conditions. Consider an experiment on the effect of a defendant’s physical attractiveness on judgments of his guilt. Again, in a between-subjects experiment, one group of participants would be shown an attractive defendant and asked to judge his guilt, and another group of participants would be shown an unattractive defendant and asked to judge his guilt. In a within-subjects experiment, however, the same group of participants would judge the guilt of both an attractive and an unattractive defendant.

The primary advantage of this approach is that it provides maximum control of extraneous participant variables. Participants in all conditions have the same mean IQ, same socioeconomic status, same number of siblings, and so on—because they are the very same people. Within-subjects experiments also make it possible to use statistical procedures that remove the effect of these extraneous participant variables on the dependent variable and therefore make the data less “noisy” and the effect of the independent variable easier to detect. We will look more closely at this idea later in the book.

Carryover Effects and Counterbalancing

The primary disadvantage of within-subjects designs is that they can result in carryover effects. A carryover effect is an effect of being tested in one condition on participants’ behavior in later conditions. One type of carryover effect is a practice effect , where participants perform a task better in later conditions because they have had a chance to practice it. Another type is a fatigue effect , where participants perform a task worse in later conditions because they become tired or bored. Being tested in one condition can also change how participants perceive stimuli or interpret their task in later conditions. This is called a context effect . For example, an average-looking defendant might be judged more harshly when participants have just judged an attractive defendant than when they have just judged an unattractive defendant. Within-subjects experiments also make it easier for participants to guess the hypothesis. For example, a participant who is asked to judge the guilt of an attractive defendant and then is asked to judge the guilt of an unattractive defendant is likely to guess that the hypothesis is that defendant attractiveness affects judgments of guilt. This could lead the participant to judge the unattractive defendant more harshly because he thinks this is what he is expected to do. Or it could make participants judge the two defendants similarly in an effort to be “fair.”

Carryover effects can be interesting in their own right. (Does the attractiveness of one person depend on the attractiveness of other people that we have seen recently?) But when they are not the focus of the research, carryover effects can be problematic. Imagine, for example, that participants judge the guilt of an attractive defendant and then judge the guilt of an unattractive defendant. If they judge the unattractive defendant more harshly, this might be because of his unattractiveness. But it could be instead that they judge him more harshly because they are becoming bored or tired. In other words, the order of the conditions is a confounding variable. The attractive condition is always the first condition and the unattractive condition the second. Thus any difference between the conditions in terms of the dependent variable could be caused by the order of the conditions and not the independent variable itself.

There is a solution to the problem of order effects, however, that can be used in many situations. It is counterbalancing , which means testing different participants in different orders. For example, some participants would be tested in the attractive defendant condition followed by the unattractive defendant condition, and others would be tested in the unattractive condition followed by the attractive condition. With three conditions, there would be six different orders (ABC, ACB, BAC, BCA, CAB, and CBA), so some participants would be tested in each of the six orders. With counterbalancing, participants are assigned to orders randomly, using the techniques we have already discussed. Thus random assignment plays an important role in within-subjects designs just as in between-subjects designs. Here, instead of randomly assigning to conditions, they are randomly assigned to different orders of conditions. In fact, it can safely be said that if a study does not involve random assignment in one form or another, it is not an experiment.

There are two ways to think about what counterbalancing accomplishes. One is that it controls the order of conditions so that it is no longer a confounding variable. Instead of the attractive condition always being first and the unattractive condition always being second, the attractive condition comes first for some participants and second for others. Likewise, the unattractive condition comes first for some participants and second for others. Thus any overall difference in the dependent variable between the two conditions cannot have been caused by the order of conditions. A second way to think about what counterbalancing accomplishes is that if there are carryover effects, it makes it possible to detect them. One can analyze the data separately for each order to see whether it had an effect.

When 9 Is “Larger” Than 221

Researcher Michael Birnbaum has argued that the lack of context provided by between-subjects designs is often a bigger problem than the context effects created by within-subjects designs. To demonstrate this, he asked one group of participants to rate how large the number 9 was on a 1-to-10 rating scale and another group to rate how large the number 221 was on the same 1-to-10 rating scale (Birnbaum, 1999). Participants in this between-subjects design gave the number 9 a mean rating of 5.13 and the number 221 a mean rating of 3.10. In other words, they rated 9 as larger than 221! According to Birnbaum, this is because participants spontaneously compared 9 with other one-digit numbers (in which case it is relatively large) and compared 221 with other three-digit numbers (in which case it is relatively small).

Simultaneous Within-Subjects Designs

So far, we have discussed an approach to within-subjects designs in which participants are tested in one condition at a time. There is another approach, however, that is often used when participants make multiple responses in each condition. Imagine, for example, that participants judge the guilt of 10 attractive defendants and 10 unattractive defendants. Instead of having people make judgments about all 10 defendants of one type followed by all 10 defendants of the other type, the researcher could present all 20 defendants in a sequence that mixed the two types. The researcher could then compute each participant’s mean rating for each type of defendant. Or imagine an experiment designed to see whether people with social anxiety disorder remember negative adjectives (e.g., “stupid,” “incompetent”) better than positive ones (e.g., “happy,” “productive”). The researcher could have participants study a single list that includes both kinds of words and then have them try to recall as many words as possible. The researcher could then count the number of each type of word that was recalled. There are many ways to determine the order in which the stimuli are presented, but one common way is to generate a different random order for each participant.

Between-Subjects or Within-Subjects?

Almost every experiment can be conducted using either a between-subjects design or a within-subjects design. This means that researchers must choose between the two approaches based on their relative merits for the particular situation.

Between-subjects experiments have the advantage of being conceptually simpler and requiring less testing time per participant. They also avoid carryover effects without the need for counterbalancing. Within-subjects experiments have the advantage of controlling extraneous participant variables, which generally reduces noise in the data and makes it easier to detect a relationship between the independent and dependent variables.

A good rule of thumb, then, is that if it is possible to conduct a within-subjects experiment (with proper counterbalancing) in the time that is available per participant—and you have no serious concerns about carryover effects—this is probably the best option. If a within-subjects design would be difficult or impossible to carry out, then you should consider a between-subjects design instead. For example, if you were testing participants in a doctor’s waiting room or shoppers in line at a grocery store, you might not have enough time to test each participant in all conditions and therefore would opt for a between-subjects design. Or imagine you were trying to reduce people’s level of prejudice by having them interact with someone of another race. A within-subjects design with counterbalancing would require testing some participants in the treatment condition first and then in a control condition. But if the treatment works and reduces people’s level of prejudice, then they would no longer be suitable for testing in the control condition. This is true for many designs that involve a treatment meant to produce long-term change in participants’ behavior (e.g., studies testing the effectiveness of psychotherapy). Clearly, a between-subjects design would be necessary here.

Remember also that using one type of design does not preclude using the other type in a different study. There is no reason that a researcher could not use both a between-subjects design and a within-subjects design to answer the same research question. In fact, professional researchers often do exactly this.

Key Takeaways

• Experiments can be conducted using either between-subjects or within-subjects designs. Deciding which to use in a particular situation requires careful consideration of the pros and cons of each approach.
• Random assignment to conditions in between-subjects experiments or to orders of conditions in within-subjects experiments is a fundamental element of experimental research. Its purpose is to control extraneous variables so that they do not become confounding variables.
• Experimental research on the effectiveness of a treatment requires both a treatment condition and a control condition, which can be a no-treatment control condition, a placebo control condition, or a waitlist control condition. Experimental treatments can also be compared with the best available alternative.

Discussion: For each of the following topics, list the pros and cons of a between-subjects and within-subjects design and decide which would be better.

• You want to test the relative effectiveness of two training programs for running a marathon.
• Using photographs of people as stimuli, you want to see if smiling people are perceived as more intelligent than people who are not smiling.
• In a field experiment, you want to see if the way a panhandler is dressed (neatly vs. sloppily) affects whether or not passersby give him any money.
• You want to see if concrete nouns (e.g., dog ) are recalled better than abstract nouns (e.g., truth ).
• Discussion: Imagine that an experiment shows that participants who receive psychodynamic therapy for a dog phobia improve more than participants in a no-treatment control group. Explain a fundamental problem with this research design and at least two ways that it might be corrected.

Birnbaum, M. H. (1999). How to show that 9 > 221: Collect judgments in a between-subjects design. Psychological Methods, 4 , 243–249.

Moseley, J. B., O’Malley, K., Petersen, N. J., Menke, T. J., Brody, B. A., Kuykendall, D. H., … Wray, N. P. (2002). A controlled trial of arthroscopic surgery for osteoarthritis of the knee. The New England Journal of Medicine, 347 , 81–88.

Price, D. D., Finniss, D. G., & Benedetti, F. (2008). A comprehensive review of the placebo effect: Recent advances and current thought. Annual Review of Psychology, 59 , 565–590.

Shapiro, A. K., & Shapiro, E. (1999). The powerful placebo: From ancient priest to modern physician . Baltimore, MD: Johns Hopkins University Press.

Research Methods in Psychology Copyright © 2016 by University of Minnesota is licensed under a Creative Commons Attribution-NonCommercial-ShareAlike 4.0 International License , except where otherwise noted.

An official website of the United States government

The .gov means it’s official. Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

The site is secure. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

• Publications
• Account settings

Preview improvements coming to the PMC website in October 2024. Learn More or Try it out now .

• Advanced Search
• Journal List
• Pediatr Investig
• v.3(4); 2019 Dec

Clinical research study designs: The essentials

Ambika g. chidambaram.

1 Children's Hospital of Philadelphia, Philadelphia Pennsylvania, USA

Maureen Josephson

In clinical research, our aim is to design a study which would be able to derive a valid and meaningful scientific conclusion using appropriate statistical methods. The conclusions derived from a research study can either improve health care or result in inadvertent harm to patients. Hence, this requires a well‐designed clinical research study that rests on a strong foundation of a detailed methodology and governed by ethical clinical principles. The purpose of this review is to provide the readers an overview of the basic study designs and its applicability in clinical research.

Introduction

In clinical research, our aim is to design a study, which would be able to derive a valid and meaningful scientific conclusion using appropriate statistical methods that can be translated to the “real world” setting. 1 Before choosing a study design, one must establish aims and objectives of the study, and choose an appropriate target population that is most representative of the population being studied. The conclusions derived from a research study can either improve health care or result in inadvertent harm to patients. Hence, this requires a well‐designed clinical research study that rests on a strong foundation of a detailed methodology and is governed by ethical principles. 2

From an epidemiological standpoint, there are two major types of clinical study designs, observational and experimental. 3 Observational studies are hypothesis‐generating studies, and they can be further divided into descriptive and analytic. Descriptive observational studies provide a description of the exposure and/or the outcome, and analytic observational studies provide a measurement of the association between the exposure and the outcome. Experimental studies, on the other hand, are hypothesis testing studies. It involves an intervention that tests the association between the exposure and outcome. Each study design is different, and so it would be important to choose a design that would most appropriately answer the question in mind and provide the most valuable information. We will be reviewing each study design in detail (Figure  1 ).

Overview of clinical research study designs

Observational study designs

Observational studies ask the following questions: what, who, where and when. There are many study designs that fall under the umbrella of descriptive study designs, and they include, case reports, case series, ecologic study, cross‐sectional study, cohort study and case‐control study (Figure  2 ).

Classification of observational study designs

Case reports and case series

Every now and then during clinical practice, we come across a case that is atypical or ‘out of the norm’ type of clinical presentation. This atypical presentation is usually described as case reports which provides a detailed and comprehensive description of the case. 4 It is one of the earliest forms of research and provides an opportunity for the investigator to describe the observations that make a case unique. There are no inferences obtained and therefore cannot be generalized to the population which is a limitation. Most often than not, a series of case reports make a case series which is an atypical presentation found in a group of patients. This in turn poses the question for a new disease entity and further queries the investigator to look into mechanistic investigative opportunities to further explore. However, in a case series, the cases are not compared to subjects without the manifestations and therefore it cannot determine which factors in the description are unique to the new disease entity.

Ecologic study

Ecological studies are observational studies that provide a description of population group characteristics. That is, it describes characteristics to all individuals within a group. For example, Prentice et al 5 measured incidence of breast cancer and per capita intake of dietary fat, and found a correlation that higher per capita intake of dietary fat was associated with an increased incidence of breast cancer. But the study does not conclude specifically which subjects with breast cancer had a higher dietary intake of fat. Thus, one of the limitations with ecologic study designs is that the characteristics are attributed to the whole group and so the individual characteristics are unknown.

Cross‐sectional study

Cross‐sectional studies are study designs used to evaluate an association between an exposure and outcome at the same time. It can be classified under either descriptive or analytic, and therefore depends on the question being answered by the investigator. Since, cross‐sectional studies are designed to collect information at the same point of time, this provides an opportunity to measure prevalence of the exposure or the outcome. For example, a cross‐sectional study design was adopted to estimate the global need for palliative care for children based on representative sample of countries from all regions of the world and all World Bank income groups. 6 The limitation of cross‐sectional study design is that temporal association cannot be established as the information is collected at the same point of time. If a study involves a questionnaire, then the investigator can ask questions to onset of symptoms or risk factors in relation to onset of disease. This would help in obtaining a temporal sequence between the exposure and outcome. 7

Case‐control study

Case‐control studies are study designs that compare two groups, such as the subjects with disease (cases) to the subjects without disease (controls), and to look for differences in risk factors. 8 This study is used to study risk factors or etiologies for a disease, especially if the disease is rare. Thus, case‐control studies can also be hypothesis testing studies and therefore can suggest a causal relationship but cannot prove. It is less expensive and less time‐consuming than cohort studies (described in section “Cohort study”). An example of a case‐control study was performed in Pakistan evaluating the risk factors for neonatal tetanus. They retrospectively reviewed a defined cohort for cases with and without neonatal tetanus. 9 They found a strong association of the application of ghee (clarified butter) as a risk factor for neonatal tetanus. Although this suggests a causal relationship, cause cannot be proven by this methodology (Figure  3 ).

Case‐control study design

One of the limitations of case‐control studies is that they cannot estimate prevalence of a disease accurately as a proportion of cases and controls are studied at a time. Case‐control studies are also prone to biases such as recall bias, as the subjects are providing information based on their memory. Hence, the subjects with disease are likely to remember the presence of risk factors compared to the subjects without disease.

One of the aspects that is often overlooked is the selection of cases and controls. It is important to select the cases and controls appropriately to obtain a meaningful and scientifically sound conclusion and this can be achieved by implementing matching. Matching is defined by Gordis et al as ‘the process of selecting the controls so that they are similar to the cases in certain characteristics such as age, race, sex, socioeconomic status and occupation’ 7 This would help identify risk factors or probable etiologies that are not due to differences between the cases and controls.

Cohort study

Cohort studies are study designs that compare two groups, such as the subjects with exposure/risk factor to the subjects without exposure/risk factor, for differences in incidence of outcome/disease. Most often, cohort study designs are used to study outcome(s) from a single exposure/risk factor. Thus, cohort studies can also be hypothesis testing studies and can infer and interpret a causal relationship between an exposure and a proposed outcome, but cannot establish it (Figure  4 ).

Cohort study design

Cohort studies can be classified as prospective and retrospective. 7 Prospective cohort studies follow subjects from presence of risk factors/exposure to development of disease/outcome. This could take up to years before development of disease/outcome, and therefore is time consuming and expensive. On the other hand, retrospective cohort studies identify a population with and without the risk factor/exposure based on past records and then assess if they had developed the disease/outcome at the time of study. Thus, the study design for prospective and retrospective cohort studies are similar as we are comparing populations with and without exposure/risk factor to development of outcome/disease.

Cohort studies are typically chosen as a study design when the suspected exposure is known and rare, and the incidence of disease/outcome in the exposure group is suspected to be high. The choice between prospective and retrospective cohort study design would depend on the accuracy and reliability of the past records regarding the exposure/risk factor.

Some of the biases observed with cohort studies include selection bias and information bias. Some individuals who have the exposure may refuse to participate in the study or would be lost to follow‐up, and in those instances, it becomes difficult to interpret the association between an exposure and outcome. Also, if the information is inaccurate when past records are used to evaluate for exposure status, then again, the association between the exposure and outcome becomes difficult to interpret.

Case‐control studies based within a defined cohort

Case‐control studies based within a defined cohort is a form of study design that combines some of the features of a cohort study design and a case‐control study design. When a defined cohort is embedded in a case‐control study design, all the baseline information collected before the onset of disease like interviews, surveys, blood or urine specimens, then the cohort is followed onset of disease. One of the advantages of following the above design is that it eliminates recall bias as the information regarding risk factors is collected before onset of disease. Case‐control studies based within a defined cohort can be further classified into two types: Nested case‐control study and Case‐cohort study.

Nested case‐control study

A nested case‐control study consists of defining a cohort with suspected risk factors and assigning a control within a cohort to the subject who develops the disease. 10 Over a period, cases and controls are identified and followed as per the investigator's protocol. Hence, the case and control are matched on calendar time and length of follow‐up. When this study design is implemented, it is possible for the control that was selected early in the study to develop the disease and become a case in the latter part of the study.

Case‐cohort Study

A case‐cohort study is similar to a nested case‐control study except that there is a defined sub‐cohort which forms the groups of individuals without the disease (control), and the cases are not matched on calendar time or length of follow‐up with the control. 11 With these modifications, it is possible to compare different disease groups with the same sub‐cohort group of controls and eliminates matching between the case and control. However, these differences will need to be accounted during analysis of results.

Experimental study design

The basic concept of experimental study design is to study the effect of an intervention. In this study design, the risk factor/exposure of interest/treatment is controlled by the investigator. Therefore, these are hypothesis testing studies and can provide the most convincing demonstration of evidence for causality. As a result, the design of the study requires meticulous planning and resources to provide an accurate result.

The experimental study design can be classified into 2 groups, that is, controlled (with comparison) and uncontrolled (without comparison). 1 In the group without controls, the outcome is directly attributed to the treatment received in one group. This fails to prove if the outcome was truly due to the intervention implemented or due to chance. This can be avoided if a controlled study design is chosen which includes a group that does not receive the intervention (control group) and a group that receives the intervention (intervention/experiment group), and therefore provide a more accurate and valid conclusion.

Experimental study designs can be divided into 3 broad categories: clinical trial, community trial, field trial. The specifics of each study design are explained below (Figure  5 ).

Experimental study designs

Clinical trial

Clinical trials are also known as therapeutic trials, which involve subjects with disease and are placed in different treatment groups. It is considered a gold standard approach for epidemiological research. One of the earliest clinical trial studies was performed by James Lind et al in 1747 on sailors with scurvy. 12 Lind divided twelve scorbutic sailors into six groups of two. Each group received the same diet, in addition to a quart of cider (group 1), twenty‐five drops of elixir of vitriol which is sulfuric acid (group 2), two spoonfuls of vinegar (group 3), half a pint of seawater (group 4), two oranges and one lemon (group 5), and a spicy paste plus a drink of barley water (group 6). The group who ate two oranges and one lemon had shown the most sudden and visible clinical effects and were taken back at the end of 6 days as being fit for duty. During Lind's time, this was not accepted but was shown to have similar results when repeated 47 years later in an entire fleet of ships. Based on the above results, in 1795 lemon juice was made a required part of the diet of sailors. Thus, clinical trials can be used to evaluate new therapies, such as new drug or new indication, new drug combination, new surgical procedure or device, new dosing schedule or mode of administration, or a new prevention therapy.

While designing a clinical trial, it is important to select the population that is best representative of the general population. Therefore, the results obtained from the study can be generalized to the population from which the sample population was selected. It is also as important to select appropriate endpoints while designing a trial. Endpoints need to be well‐defined, reproducible, clinically relevant and achievable. The types of endpoints include continuous, ordinal, rates and time‐to‐event, and it is typically classified as primary, secondary or tertiary. 2 An ideal endpoint is a purely clinical outcome, for example, cure/survival, and thus, the clinical trials will become very long and expensive trials. Therefore, surrogate endpoints are used that are biologically related to the ideal endpoint. Surrogate endpoints need to be reproducible, easily measured, related to the clinical outcome, affected by treatment and occurring earlier than clinical outcome. 2

Clinical trials are further divided into randomized clinical trial, non‐randomized clinical trial, cross‐over clinical trial and factorial clinical trial.

Randomized clinical trial

A randomized clinical trial is also known as parallel group randomized trials or randomized controlled trials. Randomized clinical trials involve randomizing subjects with similar characteristics to two groups (or multiple groups): the group that receives the intervention/experimental therapy and the other group that received the placebo (or standard of care). 13 This is typically performed by using a computer software, manually or by other methods. Hence, we can measure the outcomes and efficacy of the intervention/experimental therapy being studied without bias as subjects have been randomized to their respective groups with similar baseline characteristics. This type of study design is considered gold standard for epidemiological research. However, this study design is generally not applicable to rare and serious disease process as it would unethical to treat that group with a placebo. Please see section “Randomization” for detailed explanation regarding randomization and placebo.

Non‐randomized clinical trial

A non‐randomized clinical trial involves an approach to selecting controls without randomization. With this type of study design a pattern is usually adopted, such as, selection of subjects and controls on certain days of the week. Depending on the approach adopted, the selection of subjects becomes predictable and therefore, there is bias with regards to selection of subjects and controls that would question the validity of the results obtained.

Historically controlled studies can be considered as a subtype of non‐randomized clinical trial. In this study design subtype, the source of controls is usually adopted from the past, such as from medical records and published literature. 1 The advantages of this study design include being cost‐effective, time saving and easily accessible. However, since this design depends on already collected data from different sources, the information obtained may not be accurate, reliable, lack uniformity and/or completeness as well. Though historically controlled studies maybe easier to conduct, the disadvantages will need to be taken into account while designing a study.

Cross‐over clinical trial

In cross‐over clinical trial study design, there are two groups who undergoes the same intervention/experiment at different time periods of the study. That is, each group serves as a control while the other group is undergoing the intervention/experiment. 14 Depending on the intervention/experiment, a ‘washout’ period is recommended. This would help eliminate residuals effects of the intervention/experiment when the experiment group transitions to be the control group. Hence, the outcomes of the intervention/experiment will need to be reversible as this type of study design would not be possible if the subject is undergoing a surgical procedure.

Factorial trial

A factorial trial study design is adopted when the researcher wishes to test two different drugs with independent effects on the same population. Typically, the population is divided into 4 groups, the first with drug A, the second with drug B, the third with drug A and B, and the fourth with neither drug A nor drug B. The outcomes for drug A are compared to those on drug A, drug A and B and to those who were on drug B and neither drug A nor drug B. 15 The advantages of this study design that it saves time and helps to study two different drugs on the same study population at the same time. However, this study design would not be applicable if either of the drugs or interventions overlaps with each other on modes of action or effects, as the results obtained would not attribute to a particular drug or intervention.

Community trial

Community trials are also known as cluster‐randomized trials, involve groups of individuals with and without disease who are assigned to different intervention/experiment groups. Hence, groups of individuals from a certain area, such as a town or city, or a certain group such as school or college, will undergo the same intervention/experiment. 16 Hence, the results will be obtained at a larger scale; however, will not be able to account for inter‐individual and intra‐individual variability.

Field trial

Field trials are also known as preventive or prophylactic trials, and the subjects without the disease are placed in different preventive intervention groups. 16 One of the hypothetical examples for a field trial would be to randomly assign to groups of a healthy population and to provide an intervention to a group such as a vitamin and following through to measure certain outcomes. Hence, the subjects are monitored over a period of time for occurrence of a particular disease process.

Overview of methodologies used within a study design

Randomization.

Randomization is a well‐established methodology adopted in research to prevent bias due to subject selection, which may impact the result of the intervention/experiment being studied. It is one of the fundamental principles of an experimental study designs and ensures scientific validity. It provides a way to avoid predicting which subjects are assigned to a certain group and therefore, prevent bias on the final results due to subject selection. This also ensures comparability between groups as most baseline characteristics are similar prior to randomization and therefore helps to interpret the results regarding the intervention/experiment group without bias.

There are various ways to randomize and it can be as simple as a ‘flip of a coin’ to use computer software and statistical methods. To better describe randomization, there are three types of randomization: simple randomization, block randomization and stratified randomization.

Simple randomization

In simple randomization, the subjects are randomly allocated to experiment/intervention groups based on a constant probability. That is, if there are two groups A and B, the subject has a 0.5 probability of being allocated to either group. This can be performed in multiple ways, and one of which being as simple as a ‘flip of a coin’ to using random tables or numbers. 17 The advantage of using this methodology is that it eliminates selection bias. However, the disadvantage with this methodology is that an imbalance in the number allocated to each group as well as the prognostic factors between groups. Hence, it is more challenging in studies with a small sample size.

Block randomization

In block randomization, the subjects of similar characteristics are classified into blocks. The aim of block randomization is to balance the number of subjects allocated to each experiment/intervention group. For example, let's assume that there are four subjects in each block, and two of the four subjects in each block will be randomly allotted to each group. Therefore, there will be two subjects in one group and two subjects in the other group. 17 The disadvantage with this methodology is that there is still a component of predictability in the selection of subjects and the randomization of prognostic factors is not performed. However, it helps to control the balance between the experiment/intervention groups.

Stratified randomization

In stratified randomization, the subjects are defined based on certain strata, which are covariates. 18 For example, prognostic factors like age can be considered as a covariate, and then the specified population can be randomized within each age group related to an experiment/intervention group. The advantage with this methodology is that it enables comparability between experiment/intervention groups and thus makes result analysis more efficient. But, with this methodology the covariates will need to be measured and determined before the randomization process. The sample size will help determine the number of strata that would need to be chosen for a study.

Blinding is a methodology adopted in a study design to intentionally not provide information related to the allocation of the groups to the subject participants, investigators and/or data analysts. 19 The purpose of blinding is to decrease influence associated with the knowledge of being in a particular group on the study result. There are 3 forms of blinding: single‐blinded, double‐blinded and triple‐blinded. 1 In single‐blinded studies, otherwise called as open‐label studies, the subject participants are not revealed which group that they have been allocated to. However, the investigator and data analyst will be aware of the allocation of the groups. In double‐blinded studies, both the study participants and the investigator will be unaware of the group to which they were allocated to. Double‐blinded studies are typically used in clinical trials to test the safety and efficacy of the drugs. In triple‐blinded studies, the subject participants, investigators and data analysts will not be aware of the group allocation. Thus, triple‐blinded studies are more difficult and expensive to design but the results obtained will exclude confounding effects from knowledge of group allocation.

Blinding is especially important in studies where subjective response are considered as outcomes. This is because certain responses can be modified based on the knowledge of the experiment group that they are in. For example, a group allocated in the non‐intervention group may not feel better as they are not getting the treatment, or an investigator may pay more attention to the group receiving treatment, and thereby potentially affecting the final results. However, certain treatments cannot be blinded such as surgeries or if the treatment group requires an assessment of the effect of intervention such as quitting smoking.

Placebo is defined in the Merriam‐Webster dictionary as ‘an inert or innocuous substance used especially in controlled experiments testing the efficacy of another substance (such as drug)’. 20 A placebo is typically used in a clinical research study to evaluate the safety and efficacy of a drug/intervention. This is especially useful if the outcome measured is subjective. In clinical drug trials, a placebo is typically a drug that resembles the drug to be tested in certain characteristics such as color, size, shape and taste, but without the active substance. This helps to measure effects of just taking the drug, such as pain relief, compared to the drug with the active substance. If the effect is positive, for example, improvement in mood/pain, then it is called placebo effect. If the effect is negative, for example, worsening of mood/pain, then it is called nocebo effect. 21

The ethics of placebo‐controlled studies is complex and remains a debate in the medical research community. According to the Declaration of Helsinki on the use of placebo released in October 2013, “The benefits, risks, burdens and effectiveness of a new intervention must be tested against those of the best proven intervention(s), except in the following circumstances:

Where no proven intervention exists, the use of placebo, or no intervention, is acceptable; or

Where for compelling and scientifically sound methodological reasons the use of any intervention less effective than the best proven one, the use of placebo, or no intervention is necessary to determine the efficacy or safety of an intervention and the patients who receive any intervention less effective than the best proven one, placebo, or no intervention will not be subject to additional risks of serious or irreversible harm as a result of not receiving the best proven intervention.

Extreme care must be taken to avoid abuse of this option”. 22

Hence, while designing a research study, both the scientific validity and ethical aspects of the study will need to be thoroughly evaluated.

Bias has been defined as “any systematic error in the design, conduct or analysis of a study that results in a mistaken estimate of an exposure's effect on the risk of disease”. 23 There are multiple types of biases and so, in this review we will focus on the following types: selection bias, information bias and observer bias. Selection bias is when a systematic error is committed while selecting subjects for the study. Selection bias will affect the external validity of the study if the study subjects are not representative of the population being studied and therefore, the results of the study will not be generalizable. Selection bias will affect the internal validity of the study if the selection of study subjects in each group is influenced by certain factors, such as, based on the treatment of the group assigned. One of the ways to decrease selection bias is to select the study population that would representative of the population being studied, or to randomize (discussed in section “Randomization”).

Information bias is when a systematic error is committed while obtaining data from the study subjects. This can be in the form of recall bias when subject is required to remember certain events from the past. Typically, subjects with the disease tend to remember certain events compared to subjects without the disease. Observer bias is a systematic error when the study investigator is influenced by the certain characteristics of the group, that is, an investigator may pay closer attention to the group receiving the treatment versus the group not receiving the treatment. This may influence the results of the study. One of the ways to decrease observer bias is to use blinding (discussed in section “Blinding”).

Thus, while designing a study it is important to take measure to limit bias as much as possible so that the scientific validity of the study results is preserved to its maximum.

Overview of drug development in the United States of America

Now that we have reviewed the various clinical designs, clinical trials form a major part in development of a drug. In the United States, the Food and Drug Administration (FDA) plays an important role in getting a drug approved for clinical use. It includes a robust process that involves four different phases before a drug can be made available to the public. Phase I is conducted to determine a safe dose. The study subjects consist of normal volunteers and/or subjects with disease of interest, and the sample size is typically small and not more than 30 subjects. The primary endpoint consists of toxicity and adverse events. Phase II is conducted to evaluate of safety of dose selected in Phase I, to collect preliminary information on efficacy and to determine factors to plan a randomized controlled trial. The study subjects consist of subjects with disease of interest and the sample size is also small but more that Phase I (40–100 subjects). The primary endpoint is the measure of response. Phase III is conducted as a definitive trial to prove efficacy and establish safety of a drug. Phase III studies are randomized controlled trials and depending on the drug being studied, it can be placebo‐controlled, equivalence, superiority or non‐inferiority trials. The study subjects consist of subjects with disease of interest, and the sample size is typically large but no larger than 300 to 3000. Phase IV is performed after a drug is approved by the FDA and it is also called the post‐marketing clinical trial. This phase is conducted to evaluate new indications, to determine safety and efficacy in long‐term follow‐up and new dosing regimens. This phase helps to detect rare adverse events that would not be picked up during phase III studies and decrease in the delay in the release of the drug in the market. Hence, this phase depends heavily on voluntary reporting of side effects and/or adverse events by physicians, non‐physicians or drug companies. 2

We have discussed various clinical research study designs in this comprehensive review. Though there are various designs available, one must consider various ethical aspects of the study. Hence, each study will require thorough review of the protocol by the institutional review board before approval and implementation.

CONFLICT OF INTEREST

Chidambaram AG, Josephson M. Clinical research study designs: The essentials . Pediatr Invest . 2019; 3 :245‐252. 10.1002/ped4.12166 [ PMC free article ] [ PubMed ] [ CrossRef ] [ Google Scholar ]

Experimental Design: Types, Examples & Methods

Saul McLeod, PhD

Editor-in-Chief for Simply Psychology

BSc (Hons) Psychology, MRes, PhD, University of Manchester

Saul McLeod, PhD., is a qualified psychology teacher with over 18 years of experience in further and higher education. He has been published in peer-reviewed journals, including the Journal of Clinical Psychology.

Learn about our Editorial Process

Olivia Guy-Evans, MSc

Associate Editor for Simply Psychology

BSc (Hons) Psychology, MSc Psychology of Education

Olivia Guy-Evans is a writer and associate editor for Simply Psychology. She has previously worked in healthcare and educational sectors.

On This Page:

Experimental design refers to how participants are allocated to different groups in an experiment. Types of design include repeated measures, independent groups, and matched pairs designs.

Probably the most common way to design an experiment in psychology is to divide the participants into two groups, the experimental group and the control group, and then introduce a change to the experimental group, not the control group.

The researcher must decide how he/she will allocate their sample to the different experimental groups.  For example, if there are 10 participants, will all 10 participants participate in both groups (e.g., repeated measures), or will the participants be split in half and take part in only one group each?

Three types of experimental designs are commonly used:

1. Independent Measures

Independent measures design, also known as between-groups , is an experimental design where different participants are used in each condition of the independent variable.  This means that each condition of the experiment includes a different group of participants.

This should be done by random allocation, ensuring that each participant has an equal chance of being assigned to one group.

Independent measures involve using two separate groups of participants, one in each condition. For example:

• Con : More people are needed than with the repeated measures design (i.e., more time-consuming).
• Pro : Avoids order effects (such as practice or fatigue) as people participate in one condition only.  If a person is involved in several conditions, they may become bored, tired, and fed up by the time they come to the second condition or become wise to the requirements of the experiment!
• Con : Differences between participants in the groups may affect results, for example, variations in age, gender, or social background.  These differences are known as participant variables (i.e., a type of extraneous variable ).
• Control : After the participants have been recruited, they should be randomly assigned to their groups. This should ensure the groups are similar, on average (reducing participant variables).

2. Repeated Measures Design

Repeated Measures design is an experimental design where the same participants participate in each independent variable condition.  This means that each experiment condition includes the same group of participants.

Repeated Measures design is also known as within-groups or within-subjects design .

• Pro : As the same participants are used in each condition, participant variables (i.e., individual differences) are reduced.
• Con : There may be order effects. Order effects refer to the order of the conditions affecting the participants’ behavior.  Performance in the second condition may be better because the participants know what to do (i.e., practice effect).  Or their performance might be worse in the second condition because they are tired (i.e., fatigue effect). This limitation can be controlled using counterbalancing.
• Pro : Fewer people are needed as they participate in all conditions (i.e., saves time).
• Control : To combat order effects, the researcher counter-balances the order of the conditions for the participants.  Alternating the order in which participants perform in different conditions of an experiment.

Counterbalancing

Suppose we used a repeated measures design in which all of the participants first learned words in “loud noise” and then learned them in “no noise.”

We expect the participants to learn better in “no noise” because of order effects, such as practice. However, a researcher can control for order effects using counterbalancing.

The sample would be split into two groups: experimental (A) and control (B).  For example, group 1 does ‘A’ then ‘B,’ and group 2 does ‘B’ then ‘A.’ This is to eliminate order effects.

Although order effects occur for each participant, they balance each other out in the results because they occur equally in both groups.

3. Matched Pairs Design

A matched pairs design is an experimental design where pairs of participants are matched in terms of key variables, such as age or socioeconomic status. One member of each pair is then placed into the experimental group and the other member into the control group .

One member of each matched pair must be randomly assigned to the experimental group and the other to the control group.

• Con : If one participant drops out, you lose 2 PPs’ data.
• Pro : Reduces participant variables because the researcher has tried to pair up the participants so that each condition has people with similar abilities and characteristics.
• Con : Very time-consuming trying to find closely matched pairs.
• Pro : It avoids order effects, so counterbalancing is not necessary.
• Con : Impossible to match people exactly unless they are identical twins!
• Control : Members of each pair should be randomly assigned to conditions. However, this does not solve all these problems.

Experimental design refers to how participants are allocated to an experiment’s different conditions (or IV levels). There are three types:

1. Independent measures / between-groups : Different participants are used in each condition of the independent variable.

2. Repeated measures /within groups : The same participants take part in each condition of the independent variable.

3. Matched pairs : Each condition uses different participants, but they are matched in terms of important characteristics, e.g., gender, age, intelligence, etc.

Learning Check

Read about each of the experiments below. For each experiment, identify (1) which experimental design was used; and (2) why the researcher might have used that design.

1 . To compare the effectiveness of two different types of therapy for depression, depressed patients were assigned to receive either cognitive therapy or behavior therapy for a 12-week period.

The researchers attempted to ensure that the patients in the two groups had similar severity of depressed symptoms by administering a standardized test of depression to each participant, then pairing them according to the severity of their symptoms.

2 . To assess the difference in reading comprehension between 7 and 9-year-olds, a researcher recruited each group from a local primary school. They were given the same passage of text to read and then asked a series of questions to assess their understanding.

3 . To assess the effectiveness of two different ways of teaching reading, a group of 5-year-olds was recruited from a primary school. Their level of reading ability was assessed, and then they were taught using scheme one for 20 weeks.

At the end of this period, their reading was reassessed, and a reading improvement score was calculated. They were then taught using scheme two for a further 20 weeks, and another reading improvement score for this period was calculated. The reading improvement scores for each child were then compared.

4 . To assess the effect of the organization on recall, a researcher randomly assigned student volunteers to two conditions.

Condition one attempted to recall a list of words that were organized into meaningful categories; condition two attempted to recall the same words, randomly grouped on the page.

Experiment Terminology

Ecological validity.

The degree to which an investigation represents real-life experiences.

Experimenter effects

These are the ways that the experimenter can accidentally influence the participant through their appearance or behavior.

Demand characteristics

The clues in an experiment lead the participants to think they know what the researcher is looking for (e.g., the experimenter’s body language).

Independent variable (IV)

The variable the experimenter manipulates (i.e., changes) is assumed to have a direct effect on the dependent variable.

Dependent variable (DV)

Variable the experimenter measures. This is the outcome (i.e., the result) of a study.

Extraneous variables (EV)

All variables which are not independent variables but could affect the results (DV) of the experiment. Extraneous variables should be controlled where possible.

Confounding variables

Variable(s) that have affected the results (DV), apart from the IV. A confounding variable could be an extraneous variable that has not been controlled.

Random Allocation

Randomly allocating participants to independent variable conditions means that all participants should have an equal chance of taking part in each condition.

The principle of random allocation is to avoid bias in how the experiment is carried out and limit the effects of participant variables.

Order effects

Changes in participants’ performance due to their repeating the same or similar test more than once. Examples of order effects include:

(i) practice effect: an improvement in performance on a task due to repetition, for example, because of familiarity with the task;

(ii) fatigue effect: a decrease in performance of a task due to repetition, for example, because of boredom or tiredness.

Instant insights, infinite possibilities

Experimental design: Guide, steps, examples

Last updated

27 April 2023

Reviewed by

Miroslav Damyanov

Short on time? Get an AI generated summary of this article instead

Experimental research design is a scientific framework that allows you to manipulate one or more variables while controlling the test environment. 

When testing a theory or new product, it can be helpful to have a certain level of control and manipulate variables to discover different outcomes. You can use these experiments to determine cause and effect or study variable associations. 

This guide explores the types of experimental design, the steps in designing an experiment, and the advantages and limitations of experimental design. 

Make research less tedious

Dovetail streamlines research to help you uncover and share actionable insights

• What is experimental research design?

You can determine the relationship between each of the variables by: 

Manipulating one or more independent variables (i.e., stimuli or treatments)

Applying the changes to one or more dependent variables (i.e., test groups or outcomes)

With the ability to analyze the relationship between variables and using measurable data, you can increase the accuracy of the result. 

What is a good experimental design?

A good experimental design requires: 

Significant planning to ensure control over the testing environment

Sound experimental treatments

Properly assigning subjects to treatment groups

Without proper planning, unexpected external variables can alter an experiment's outcome. 

To meet your research goals, your experimental design should include these characteristics:

Provide unbiased estimates of inputs and associated uncertainties

Enable the researcher to detect differences caused by independent variables

Include a plan for analysis and reporting of the results

Provide easily interpretable results with specific conclusions

What's the difference between experimental and quasi-experimental design?

The major difference between experimental and quasi-experimental design is the random assignment of subjects to groups. 

A true experiment relies on certain controls. Typically, the researcher designs the treatment and randomly assigns subjects to control and treatment groups. 

However, these conditions are unethical or impossible to achieve in some situations.

When it's unethical or impractical to assign participants randomly, that’s when a quasi-experimental design comes in. 

This design allows researchers to conduct a similar experiment by assigning subjects to groups based on non-random criteria. 

Another type of quasi-experimental design might occur when the researcher doesn't have control over the treatment but studies pre-existing groups after they receive different treatments.

When can a researcher conduct experimental research?

Various settings and professions can use experimental research to gather information and observe behavior in controlled settings. 

Basically, a researcher can conduct experimental research any time they want to test a theory with variable and dependent controls. 

Experimental research is an option when the project includes an independent variable and a desire to understand the relationship between cause and effect. 

• The importance of experimental research design

Experimental research enables researchers to conduct studies that provide specific, definitive answers to questions and hypotheses. 

Researchers can test Independent variables in controlled settings to:

Test the effectiveness of a new medication

Design better products for consumers

Answer questions about human health and behavior

Developing a quality research plan means a researcher can accurately answer vital research questions with minimal error. As a result, definitive conclusions can influence the future of the independent variable. 

Types of experimental research designs

There are three main types of experimental research design. The research type you use will depend on the criteria of your experiment, your research budget, and environmental limitations. 

Pre-experimental research design

A pre-experimental research study is a basic observational study that monitors independent variables’ effects. 

During research, you observe one or more groups after applying a treatment to test whether the treatment causes any change. 

The three subtypes of pre-experimental research design are:

One-shot case study research design

This research method introduces a single test group to a single stimulus to study the results at the end of the application. 

After researchers presume the stimulus or treatment has caused changes, they gather results to determine how it affects the test subjects. 

One-group pretest-posttest design

This method uses a single test group but includes a pretest study as a benchmark. The researcher applies a test before and after the group’s exposure to a specific stimulus. 

Static group comparison design

This method includes two or more groups, enabling the researcher to use one group as a control. They apply a stimulus to one group and leave the other group static. 

A posttest study compares the results among groups. 

True experimental research design

A true experiment is the most common research method. It involves statistical analysis to prove or disprove a specific hypothesis . 

Under completely experimental conditions, researchers expose participants in two or more randomized groups to different stimuli. 

Random selection removes any potential for bias, providing more reliable results. 

These are the three main sub-groups of true experimental research design:

Posttest-only control group design

This structure requires the researcher to divide participants into two random groups. One group receives no stimuli and acts as a control while the other group experiences stimuli.

Researchers perform a test at the end of the experiment to observe the stimuli exposure results.

Pretest-posttest control group design

This test also requires two groups. It includes a pretest as a benchmark before introducing the stimulus. 

The pretest introduces multiple ways to test subjects. For instance, if the control group also experiences a change, it reveals that taking the test twice changes the results.

Solomon four-group design

This structure divides subjects into two groups, with two as control groups. Researchers assign the first control group a posttest only and the second control group a pretest and a posttest. 

The two variable groups mirror the control groups, but researchers expose them to stimuli. The ability to differentiate between groups in multiple ways provides researchers with more testing approaches for data-based conclusions. 

Quasi-experimental research design

Although closely related to a true experiment, quasi-experimental research design differs in approach and scope. 

Quasi-experimental research design doesn’t have randomly selected participants. Researchers typically divide the groups in this research by pre-existing differences. 

Quasi-experimental research is more common in educational studies, nursing, or other research projects where it's not ethical or practical to use randomized subject groups.

• 5 steps for designing an experiment

Experimental research requires a clearly defined plan to outline the research parameters and expected goals. 

Here are five key steps in designing a successful experiment:

Step 1: Define variables and their relationship

Your experiment should begin with a question: What are you hoping to learn through your experiment? 

The relationship between variables in your study will determine your answer.

Define the independent variable (the intended stimuli) and the dependent variable (the expected effect of the stimuli). After identifying these groups, consider how you might control them in your experiment. 

Could natural variations affect your research? If so, your experiment should include a pretest and posttest. 

Step 2: Develop a specific, testable hypothesis

With a firm understanding of the system you intend to study, you can write a specific, testable hypothesis. 

What is the expected outcome of your study? 

Develop a prediction about how the independent variable will affect the dependent variable. 

How will the stimuli in your experiment affect your test subjects? 

Your hypothesis should provide a prediction of the answer to your research question . 

Step 3: Design experimental treatments to manipulate your independent variable

Depending on your experiment, your variable may be a fixed stimulus (like a medical treatment) or a variable stimulus (like a period during which an activity occurs). 

Determine which type of stimulus meets your experiment’s needs and how widely or finely to vary your stimuli. 

Step 4: Assign subjects to groups

When you have a clear idea of how to carry out your experiment, you can determine how to assemble test groups for an accurate study. 

When choosing your study groups, consider: 

The size of your experiment

Whether you can select groups randomly

Your target audience for the outcome of the study

You should be able to create groups with an equal number of subjects and include subjects that match your target audience. Remember, you should assign one group as a control and use one or more groups to study the effects of variables. 

Step 5: Plan how to measure your dependent variable

This step determines how you'll collect data to determine the study's outcome. You should seek reliable and valid measurements that minimize research bias or error. 

You can measure some data with scientific tools, while you’ll need to operationalize other forms to turn them into measurable observations.

• Advantages of experimental research

Experimental research is an integral part of our world. It allows researchers to conduct experiments that answer specific questions. 

While researchers use many methods to conduct different experiments, experimental research offers these distinct benefits:

Researchers can determine cause and effect by manipulating variables.

It gives researchers a high level of control.

Researchers can test multiple variables within a single experiment.

All industries and fields of knowledge can use it. 

Researchers can duplicate results to promote the validity of the study .

Replicating natural settings rapidly means immediate research.

Researchers can combine it with other research methods.

It provides specific conclusions about the validity of a product, theory, or idea.

• Disadvantages (or limitations) of experimental research

Unfortunately, no research type yields ideal conditions or perfect results. 

While experimental research might be the right choice for some studies, certain conditions could render experiments useless or even dangerous. 

Before conducting experimental research, consider these disadvantages and limitations:

Required professional qualification

Only competent professionals with an academic degree and specific training are qualified to conduct rigorous experimental research. This ensures results are unbiased and valid. 

Limited scope

Experimental research may not capture the complexity of some phenomena, such as social interactions or cultural norms. These are difficult to control in a laboratory setting.

Resource-intensive

Experimental research can be expensive, time-consuming, and require significant resources, such as specialized equipment or trained personnel.

Limited generalizability

The controlled nature means the research findings may not fully apply to real-world situations or people outside the experimental setting.

Practical or ethical concerns

Some experiments may involve manipulating variables that could harm participants or violate ethical guidelines . 

Researchers must ensure their experiments do not cause harm or discomfort to participants. 

Sometimes, recruiting a sample of people to randomly assign may be difficult. 

• Experimental research design example

Experiments across all industries and research realms provide scientists, developers, and other researchers with definitive answers. These experiments can solve problems, create inventions, and heal illnesses. 

Product design testing is an excellent example of experimental research. 

A company in the product development phase creates multiple prototypes for testing. With a randomized selection, researchers introduce each test group to a different prototype. 

When groups experience different product designs , the company can assess which option most appeals to potential customers. 

Experimental research design provides researchers with a controlled environment to conduct experiments that evaluate cause and effect. 

Using the five steps to develop a research plan ensures you anticipate and eliminate external variables while answering life’s crucial questions.

Should you be using a customer insights hub?

Do you want to discover previous research faster?

Do you share your research findings with others?

Do you analyze research data?

Start for free today, add your research, and get to key insights faster

Editor’s picks

Last updated: 18 April 2023

Last updated: 27 February 2023

Last updated: 22 August 2024

Last updated: 5 February 2023

Last updated: 16 August 2024

Last updated: 9 March 2023

Last updated: 30 April 2024

Last updated: 12 December 2023

Last updated: 11 March 2024

Last updated: 4 July 2024

Last updated: 6 March 2024

Last updated: 5 March 2024

Last updated: 13 May 2024

Latest articles

Related topics, .css-je19u9{-webkit-align-items:flex-end;-webkit-box-align:flex-end;-ms-flex-align:flex-end;align-items:flex-end;display:-webkit-box;display:-webkit-flex;display:-ms-flexbox;display:flex;-webkit-flex-direction:row;-ms-flex-direction:row;flex-direction:row;-webkit-box-flex-wrap:wrap;-webkit-flex-wrap:wrap;-ms-flex-wrap:wrap;flex-wrap:wrap;-webkit-box-pack:center;-ms-flex-pack:center;-webkit-justify-content:center;justify-content:center;row-gap:0;text-align:center;max-width:671px;}@media (max-width: 1079px){.css-je19u9{max-width:400px;}.css-je19u9>span{white-space:pre;}}@media (max-width: 799px){.css-je19u9{max-width:400px;}.css-je19u9>span{white-space:pre;}} decide what to .css-1kiodld{max-height:56px;display:-webkit-box;display:-webkit-flex;display:-ms-flexbox;display:flex;-webkit-align-items:center;-webkit-box-align:center;-ms-flex-align:center;align-items:center;}@media (max-width: 1079px){.css-1kiodld{display:none;}} build next, decide what to build next.

• Types of experimental

Log in or sign up

Get started for free

Experimental Design: An Introduction

• Reference work entry
• First Online: 01 January 2014
• Cite this reference work entry

• Klaus Hinkelmann 2  

193 Accesses

2 Citations

Experimental sciences and industrial research depend on data to draw inferences and make recommendations. Data are obtained in essentially two ways: from observational studies or from experimental; i.e., interventional, studies. The distinction between these two types of studies is important, because only experimental studies can lead to causal inferences. In order to ensure that proper inferences can be drawn, any such experiment has to be planned carefully subjectto certain principles of design of experiments.

Steps of Designed Investigations

Any investigation begins with the formulation of a question or research hypothesis in the context of a particular subject matter area, such as agriculture, medicine, industry, etc. For a given situation the researcher has to identify and characterize the experimental units to be used in the experiment. The experimental units are then subjected to different treatments, which are the objective of the study and about which statistical and...

This is a preview of subscription content, log in via an institution to check access.

Access this chapter

Subscribe and save.

• Get 10 units per month
• Download Article/Chapter or eBook
• 1 Unit = 1 Article or 1 Chapter
• Cancel anytime
• Available as PDF
• Read on any device
• Instant download
• Own it forever
• Available as EPUB and PDF
• Durable hardcover edition
• Dispatched in 3 to 5 business days
• Free shipping worldwide - see info

Tax calculation will be finalised at checkout

Purchases are for personal use only

Institutional subscriptions

References and Further Reading

Cox DR (1984) Interaction (with discussion). Int Stat Rev 52:1–32

MATH   Google Scholar  

Fisher RA (1926) The arrangement of field experiments. J Min Agr Engl 33:503–513

Google Scholar  

Fisher RA (1935) The design of experiments. Oliver and Boyd, Edinburgh

Hinkelmann K, Kempthorne O (2008) Design and analysis of experiments, vol 1: introduction to experimental design, 2nd edn. Wiley, Hoboken

Download references

Author information

Authors and affiliations.

Department of Statistics, Virginia Polytechnic Institute and State University, Blacksburg, VA, USA

Klaus Hinkelmann

You can also search for this author in PubMed   Google Scholar

Editor information

Editors and affiliations.

Department of Statistics and Informatics, Faculty of Economics, University of Kragujevac, City of Kragujevac, Serbia

Miodrag Lovric

Rights and permissions

Reprints and permissions

Copyright information

© 2011 Springer-Verlag Berlin Heidelberg

About this entry

Cite this entry.

Hinkelmann, K. (2011). Experimental Design: An Introduction. In: Lovric, M. (eds) International Encyclopedia of Statistical Science. Springer, Berlin, Heidelberg. https://doi.org/10.1007/978-3-642-04898-2_311

Download citation

DOI : https://doi.org/10.1007/978-3-642-04898-2_311

Published : 02 December 2014

Publisher Name : Springer, Berlin, Heidelberg

Print ISBN : 978-3-642-04897-5

Online ISBN : 978-3-642-04898-2

eBook Packages : Mathematics and Statistics Reference Module Computer Science and Engineering

Share this entry

Anyone you share the following link with will be able to read this content:

Sorry, a shareable link is not currently available for this article.

Provided by the Springer Nature SharedIt content-sharing initiative

• Publish with us

Policies and ethics

• Find a journal
• Track your research

Teach yourself statistics

Experimental Design

The term experimental design refers to a plan for assigning experimental units to treatment conditions.

Note: Your browser does not support HTML5 video. If you view this web page on a different browser (e.g., a recent version of Edge, Chrome, Firefox, or Opera), you can watch a video treatment of this lesson.

A good experimental design serves three purposes.

• Causation . It allows the experimenter to make causal inferences about the relationship between independent variables and a dependent variable .
• Control . It allows the experimenter to rule out alternative explanations due to the confounding effects of extraneous variables (i.e., variables other than the independent variables).
• Variability . It reduces variability within treatment conditions, which makes it easier to detect differences in treatment outcomes.

An Experimental Design Example

Consider the following hypothetical experiment. Acme Medicine is conducting an experiment to test a new vaccine, developed to immunize people against the common cold. To test the vaccine, Acme has 1000 volunteers - 500 men and 500 women. The participants range in age from 21 to 70.

In this lesson, we describe three experimental designs - a completely randomized design, a randomized block design, and a matched pairs design. And we show how each design might be applied by Acme Medicine to understand the effect of the vaccine, while ruling out confounding effects of other factors.

Completely Randomized Design

The completely randomized design is probably the simplest experimental design, in terms of data analysis and convenience. With this design, participants are randomly assigned to treatments. A completely randomized design for the Acme Experiment is shown in the table below.

In this design, the experimenter randomly assigned participants to one of two treatment conditions. They received a placebo or they received the vaccine. The same number of participants (500) were assigned to each treatment condition (although this is not required). The dependent variable is the number of colds reported in each treatment condition. If the vaccine is effective, participants in the "vaccine" condition should report significantly fewer colds than participants in the "placebo" condition.

A completely randomized design relies on randomization to control for the effects of lurking variables variables. Lurking variables are potential causal variables that were not included explicitly in the study. By randomly assigning subjects to treatments, the experimenter assumes that, on averge, lurking variables will affect each treatment condition equally; so any significant differences between conditions can fairly be attributed to the independent variable.

Randomized Block Design

With a randomized block design , the experimenter divides participants into subgroups called blocks , such that the variability within blocks is less than the variability between blocks. Then, participants within each block are randomly assigned to treatment conditions. Because this design reduces variability and potential confounding, it produces a better estimate of treatment effects. The table below shows a randomized block design for the Acme experiment.

Participants are assigned to blocks, based on gender. Then, within each block, participants are randomly assigned to treatments. For this design, 250 men get the placebo, 250 men get the vaccine, 250 women get the placebo, and 250 women get the vaccine.

It is known that men and women are physiologically different and react differently to medication. This design ensures that each treatment condition has an equal proportion of men and women. As a result, differences between treatment conditions cannot be attributed to gender. This randomized block design removes gender as a potential source of variability and as a potential confounding variable.

In this Acme example, the randomized block design is an improvement over the completely randomized design. Both designs use randomization to implicitly guard against confounding. But only the randomized block design explicitly controls for gender.

Note 1: In some blocking designs, individual participants may receive multiple treatments. This is called using the participant as his own control . Using the participant as his own control is desirable in some experiments (e.g., research on learning or fatigue). But it can also be a problem (e.g., medical studies where the medicine used in one treatment might interact with the medicine used in another treatment).

Note 2: Blocks perform a similar function in experimental design as strata perform in sampling. Both divide observations into subgroups. However, they are not the same. Blocking is associated with experimental design, and stratification is associated with survey sampling.

Matched Pairs Design

A matched pairs design is a special case of the randomized block design. It is used when the experiment has only two treatment conditions; and participants can be grouped into pairs, based on one or more blocking variables. Then, within each pair, participants are randomly assigned to different treatments. The table below shows a matched pairs design for the Acme experiment.

The 1000 participants are grouped into 500 matched pairs. Each pair is matched on gender and age. For example, Pair 1 might be two women, both age 21. Pair 2 might be two women, both age 22, and so on. This design provides explicit control for two potential lurking variables - age and gender. (And randomization controls for effects of lurking variables that were not included explicitly in the design.)

Test Your Understanding

Which of the following statements are true?

I. A completely randomized design offers no control for lurking variables. II. A randomized block design controls for the placebo effect. III. In a matched pairs design, participants within each pair receive the same treatment.

(A) I only (B) II only (C) III only (D) All of the above. (E) None of the above.

The correct answer is (E). In a completely randomized design , experimental units are randomly assigned to treatment conditions. Randomization provides some control for lurking variables . By itself, a randomized block design does not control for the placebo effect . To control for the placebo effect, the experimenter must include a placebo in one of the treatment levels. In a matched pairs design , experimental units within each pair are assigned to different treatment levels.

Want to create or adapt books like this? Learn more about how Pressbooks supports open publishing practices.

8.1 Experimental design: What is it and when should it be used?

Learning objectives.

• Define experiment
• Identify the core features of true experimental designs
• Describe the difference between an experimental group and a control group
• Identify and describe the various types of true experimental designs

Experiments are an excellent data collection strategy for social workers wishing to observe the effects of a clinical intervention or social welfare program. Understanding what experiments are and how they are conducted is useful for all social scientists, whether they actually plan to use this methodology or simply aim to understand findings from experimental studies. An experiment is a method of data collection designed to test hypotheses under controlled conditions. In social scientific research, the term experiment has a precise meaning and should not be used to describe all research methodologies.

Experiments have a long and important history in social science. Behaviorists such as John Watson, B. F. Skinner, Ivan Pavlov, and Albert Bandura used experimental design to demonstrate the various types of conditioning. Using strictly controlled environments, behaviorists were able to isolate a single stimulus as the cause of measurable differences in behavior or physiological responses. The foundations of social learning theory and behavior modification are found in experimental research projects. Moreover, behaviorist experiments brought psychology and social science away from the abstract world of Freudian analysis and towards empirical inquiry, grounded in real-world observations and objectively-defined variables. Experiments are used at all levels of social work inquiry, including agency-based experiments that test therapeutic interventions and policy experiments that test new programs.

Several kinds of experimental designs exist. In general, designs considered to be true experiments contain three basic key features:

• random assignment of participants into experimental and control groups
• a “treatment” (or intervention) provided to the experimental group
• measurement of the effects of the treatment in a post-test administered to both groups

Some true experiments are more complex.  Their designs can also include a pre-test and can have more than two groups, but these are the minimum requirements for a design to be a true experiment.

Experimental and control groups

In a true experiment, the effect of an intervention is tested by comparing two groups: one that is exposed to the intervention (the experimental group , also known as the treatment group) and another that does not receive the intervention (the control group ). Importantly, participants in a true experiment need to be randomly assigned to either the control or experimental groups. Random assignment uses a random number generator or some other random process to assign people into experimental and control groups. Random assignment is important in experimental research because it helps to ensure that the experimental group and control group are comparable and that any differences between the experimental and control groups are due to random chance. We will address more of the logic behind random assignment in the next section.

Treatment or intervention

In an experiment, the independent variable is receiving the intervention being tested—for example, a therapeutic technique, prevention program, or access to some service or support. It is less common in of social work research, but social science research may also have a stimulus, rather than an intervention as the independent variable. For example, an electric shock or a reading about death might be used as a stimulus to provoke a response.

In some cases, it may be immoral to withhold treatment completely from a control group within an experiment. If you recruited two groups of people with severe addiction and only provided treatment to one group, the other group would likely suffer. For these cases, researchers use a control group that receives “treatment as usual.” Experimenters must clearly define what treatment as usual means. For example, a standard treatment in substance abuse recovery is attending Alcoholics Anonymous or Narcotics Anonymous meetings. A substance abuse researcher conducting an experiment may use twelve-step programs in their control group and use their experimental intervention in the experimental group. The results would show whether the experimental intervention worked better than normal treatment, which is useful information.

The dependent variable is usually the intended effect the researcher wants the intervention to have. If the researcher is testing a new therapy for individuals with binge eating disorder, their dependent variable may be the number of binge eating episodes a participant reports. The researcher likely expects her intervention to decrease the number of binge eating episodes reported by participants. Thus, she must, at a minimum, measure the number of episodes that occur after the intervention, which is the post-test .  In a classic experimental design, participants are also given a pretest to measure the dependent variable before the experimental treatment begins.

Types of experimental design

Let’s put these concepts in chronological order so we can better understand how an experiment runs from start to finish. Once you’ve collected your sample, you’ll need to randomly assign your participants to the experimental group and control group. In a common type of experimental design, you will then give both groups your pretest, which measures your dependent variable, to see what your participants are like before you start your intervention. Next, you will provide your intervention, or independent variable, to your experimental group, but not to your control group. Many interventions last a few weeks or months to complete, particularly therapeutic treatments. Finally, you will administer your post-test to both groups to observe any changes in your dependent variable. What we’ve just described is known as the classical experimental design and is the simplest type of true experimental design. All of the designs we review in this section are variations on this approach. Figure 8.1 visually represents these steps.

An interesting example of experimental research can be found in Shannon K. McCoy and Brenda Major’s (2003) study of people’s perceptions of prejudice. In one portion of this multifaceted study, all participants were given a pretest to assess their levels of depression. No significant differences in depression were found between the experimental and control groups during the pretest. Participants in the experimental group were then asked to read an article suggesting that prejudice against their own racial group is severe and pervasive, while participants in the control group were asked to read an article suggesting that prejudice against a racial group other than their own is severe and pervasive. Clearly, these were not meant to be interventions or treatments to help depression, but were stimuli designed to elicit changes in people’s depression levels. Upon measuring depression scores during the post-test period, the researchers discovered that those who had received the experimental stimulus (the article citing prejudice against their same racial group) reported greater depression than those in the control group. This is just one of many examples of social scientific experimental research.

In addition to classic experimental design, there are two other ways of designing experiments that are considered to fall within the purview of “true” experiments (Babbie, 2010; Campbell & Stanley, 1963).  The posttest-only control group design is almost the same as classic experimental design, except it does not use a pretest. Researchers who use posttest-only designs want to eliminate testing effects , in which participants’ scores on a measure change because they have already been exposed to it. If you took multiple SAT or ACT practice exams before you took the real one you sent to colleges, you’ve taken advantage of testing effects to get a better score. Considering the previous example on racism and depression, participants who are given a pretest about depression before being exposed to the stimulus would likely assume that the intervention is designed to address depression. That knowledge could cause them to answer differently on the post-test than they otherwise would. In theory, as long as the control and experimental groups have been determined randomly and are therefore comparable, no pretest is needed. However, most researchers prefer to use pretests in case randomization did not result in equivalent groups and to help assess change over time within both the experimental and control groups.

Researchers wishing to account for testing effects but also gather pretest data can use a Solomon four-group design. In the Solomon four-group design , the researcher uses four groups. Two groups are treated as they would be in a classic experiment—pretest, experimental group intervention, and post-test. The other two groups do not receive the pretest, though one receives the intervention. All groups are given the post-test. Table 8.1 illustrates the features of each of the four groups in the Solomon four-group design. By having one set of experimental and control groups that complete the pretest (Groups 1 and 2) and another set that does not complete the pretest (Groups 3 and 4), researchers using the Solomon four-group design can account for testing effects in their analysis.

Solomon four-group designs are challenging to implement in the real world because they are time- and resource-intensive. Researchers must recruit enough participants to create four groups and implement interventions in two of them.

Overall, true experimental designs are sometimes difficult to implement in a real-world practice environment. It may be impossible to withhold treatment from a control group or randomly assign participants in a study. In these cases, pre-experimental and quasi-experimental designs–which we  will discuss in the next section–can be used.  However, the differences in rigor from true experimental designs leave their conclusions more open to critique.

Experimental design in macro-level research

You can imagine that social work researchers may be limited in their ability to use random assignment when examining the effects of governmental policy on individuals.  For example, it is unlikely that a researcher could randomly assign some states to implement decriminalization of recreational marijuana and some states not to in order to assess the effects of the policy change.  There are, however, important examples of policy experiments that use random assignment, including the Oregon Medicaid experiment. In the Oregon Medicaid experiment, the wait list for Oregon was so long, state officials conducted a lottery to see who from the wait list would receive Medicaid (Baicker et al., 2013).  Researchers used the lottery as a natural experiment that included random assignment. People selected to be a part of Medicaid were the experimental group and those on the wait list were in the control group. There are some practical complications macro-level experiments, just as with other experiments.  For example, the ethical concern with using people on a wait list as a control group exists in macro-level research just as it does in micro-level research.

Key Takeaways

• True experimental designs require random assignment.
• Control groups do not receive an intervention, and experimental groups receive an intervention.
• The basic components of a true experiment include a pretest, posttest, control group, and experimental group.
• Testing effects may cause researchers to use variations on the classic experimental design.
• Classic experimental design- uses random assignment, an experimental and control group, as well as pre- and posttesting
• Control group- the group in an experiment that does not receive the intervention
• Experiment- a method of data collection designed to test hypotheses under controlled conditions
• Experimental group- the group in an experiment that receives the intervention
• Posttest- a measurement taken after the intervention
• Posttest-only control group design- a type of experimental design that uses random assignment, and an experimental and control group, but does not use a pretest
• Pretest- a measurement taken prior to the intervention
• Random assignment-using a random process to assign people into experimental and control groups
• Solomon four-group design- uses random assignment, two experimental and two control groups, pretests for half of the groups, and posttests for all
• Testing effects- when a participant’s scores on a measure change because they have already been exposed to it
• True experiments- a group of experimental designs that contain independent and dependent variables, pretesting and post testing, and experimental and control groups

Image attributions

exam scientific experiment by mohamed_hassan CC-0

Foundations of Social Work Research Copyright © 2020 by Rebecca L. Mauldin is licensed under a Creative Commons Attribution-NonCommercial-ShareAlike 4.0 International License , except where otherwise noted.

Share This Book

Statistical Design and Analysis of Biological Experiments

Chapter 1 principles of experimental design, 1.1 introduction.

The validity of conclusions drawn from a statistical analysis crucially hinges on the manner in which the data are acquired, and even the most sophisticated analysis will not rescue a flawed experiment. Planning an experiment and thinking about the details of data acquisition is so important for a successful analysis that R. A. Fisher—who single-handedly invented many of the experimental design techniques we are about to discuss—famously wrote

To call in the statistician after the experiment is done may be no more than asking him to perform a post-mortem examination: he may be able to say what the experiment died of. ( Fisher 1938 )

(Statistical) design of experiments provides the principles and methods for planning experiments and tailoring the data acquisition to an intended analysis. Design and analysis of an experiment are best considered as two aspects of the same enterprise: the goals of the analysis strongly inform an appropriate design, and the implemented design determines the possible analyses.

The primary aim of designing experiments is to ensure that valid statistical and scientific conclusions can be drawn that withstand the scrutiny of a determined skeptic. Good experimental design also considers that resources are used efficiently, and that estimates are sufficiently precise and hypothesis tests adequately powered. It protects our conclusions by excluding alternative interpretations or rendering them implausible. Three main pillars of experimental design are randomization , replication , and blocking , and we will flesh out their effects on the subsequent analysis as well as their implementation in an experimental design.

An experimental design is always tailored towards predefined (primary) analyses and an efficient analysis and unambiguous interpretation of the experimental data is often straightforward from a good design. This does not prevent us from doing additional analyses of interesting observations after the data are acquired, but these analyses can be subjected to more severe criticisms and conclusions are more tentative.

In this chapter, we provide the wider context for using experiments in a larger research enterprise and informally introduce the main statistical ideas of experimental design. We use a comparison of two samples as our main example to study how design choices affect an analysis, but postpone a formal quantitative analysis to the next chapters.

1.2 A Cautionary Tale

For illustrating some of the issues arising in the interplay of experimental design and analysis, we consider a simple example. We are interested in comparing the enzyme levels measured in processed blood samples from laboratory mice, when the sample processing is done either with a kit from a vendor A, or a kit from a competitor B. For this, we take 20 mice and randomly select 10 of them for sample preparation with kit A, while the blood samples of the remaining 10 mice are prepared with kit B. The experiment is illustrated in Figure 1.1 A and the resulting data are given in Table 1.1 .

One option for comparing the two kits is to look at the difference in average enzyme levels, and we find an average level of 10.32 for vendor A and 10.66 for vendor B. We would like to interpret their difference of -0.34 as the difference due to the two preparation kits and conclude whether the two kits give equal results or if measurements based on one kit are systematically different from those based on the other kit.

Such interpretation, however, is only valid if the two groups of mice and their measurements are identical in all aspects except the sample preparation kit. If we use one strain of mice for kit A and another strain for kit B, any difference might also be attributed to inherent differences between the strains. Similarly, if the measurements using kit B were conducted much later than those using kit A, any observed difference might be attributed to changes in, e.g., mice selected, batches of chemicals used, device calibration, or any number of other influences. None of these competing explanations for an observed difference can be excluded from the given data alone, but good experimental design allows us to render them (almost) arbitrarily implausible.

A second aspect for our analysis is the inherent uncertainty in our calculated difference: if we repeat the experiment, the observed difference will change each time, and this will be more pronounced for a smaller number of mice, among others. If we do not use a sufficient number of mice in our experiment, the uncertainty associated with the observed difference might be too large, such that random fluctuations become a plausible explanation for the observed difference. Systematic differences between the two kits, of practically relevant magnitude in either direction, might then be compatible with the data, and we can draw no reliable conclusions from our experiment.

In each case, the statistical analysis—no matter how clever—was doomed before the experiment was even started, while simple ideas from statistical design of experiments would have provided correct and robust results with interpretable conclusions.

1.3 The Language of Experimental Design

By an experiment we understand an investigation where the researcher has full control over selecting and altering the experimental conditions of interest, and we only consider investigations of this type. The selected experimental conditions are called treatments . An experiment is comparative if the responses to several treatments are to be compared or contrasted. The experimental units are the smallest subdivision of the experimental material to which a treatment can be assigned. All experimental units given the same treatment constitute a treatment group . Especially in biology, we often compare treatments to a control group to which some standard experimental conditions are applied; a typical example is using a placebo for the control group, and different drugs for the other treatment groups.

The values observed are called responses and are measured on the response units ; these are often identical to the experimental units but need not be. Multiple experimental units are sometimes combined into groupings or blocks , such as mice grouped by litter, or samples grouped by batches of chemicals used for their preparation. More generally, we call any grouping of the experimental material (even with group size one) a unit .

In our example, we selected the mice, used a single sample per mouse, deliberately chose the two specific vendors, and had full control over which kit to assign to which mouse. In other words, the two kits are the treatments and the mice are the experimental units. We took the measured enzyme level of a single sample from a mouse as our response, and samples are therefore the response units. The resulting experiment is comparative, because we contrast the enzyme levels between the two treatment groups.

Figure 1.1: Three designs to determine the difference between two preparation kits A and B based on four mice. A: One sample per mouse. Comparison between averages of samples with same kit. B: Two samples per mouse treated with the same kit. Comparison between averages of mice with same kit requires averaging responses for each mouse first. C: Two samples per mouse each treated with different kit. Comparison between two samples of each mouse, with differences averaged.

In this example, we can coalesce experimental and response units, because we have a single response per mouse and cannot distinguish a sample from a mouse in the analysis, as illustrated in Figure 1.1 A for four mice. Responses from mice with the same kit are averaged, and the kit difference is the difference between these two averages.

By contrast, if we take two samples per mouse and use the same kit for both samples, then the mice are still the experimental units, but each mouse now groups the two response units associated with it. Now, responses from the same mouse are first averaged, and these averages are used to calculate the difference between kits; even though eight measurements are available, this difference is still based on only four mice (Figure 1.1 B).

If we take two samples per mouse, but apply each kit to one of the two samples, then the samples are both the experimental and response units, while the mice are blocks that group the samples. Now, we calculate the difference between kits for each mouse, and then average these differences (Figure 1.1 C).

If we only use one kit and determine the average enzyme level, then this investigation is still an experiment, but is not comparative.

To summarize, the design of an experiment determines the logical structure of the experiment ; it consists of (i) a set of treatments (the two kits); (ii) a specification of the experimental units (animals, cell lines, samples) (the mice in Figure 1.1 A,B and the samples in Figure 1.1 C); (iii) a procedure for assigning treatments to units; and (iv) a specification of the response units and the quantity to be measured as a response (the samples and associated enzyme levels).

1.4 Experiment Validity

Before we embark on the more technical aspects of experimental design, we discuss three components for evaluating an experiment’s validity: construct validity , internal validity , and external validity . These criteria are well-established in areas such as educational and psychological research, and have more recently been discussed for animal research ( Würbel 2017 ) where experiments are increasingly scrutinized for their scientific rationale and their design and intended analyses.

1.4.1 Construct Validity

Construct validity concerns the choice of the experimental system for answering our research question. Is the system even capable of providing a relevant answer to the question?

Studying the mechanisms of a particular disease, for example, might require careful choice of an appropriate animal model that shows a disease phenotype and is accessible to experimental interventions. If the animal model is a proxy for drug development for humans, biological mechanisms must be sufficiently similar between animal and human physiologies.

Another important aspect of the construct is the quantity that we intend to measure (the measurand ), and its relation to the quantity or property we are interested in. For example, we might measure the concentration of the same chemical compound once in a blood sample and once in a highly purified sample, and these constitute two different measurands, whose values might not be comparable. Often, the quantity of interest (e.g., liver function) is not directly measurable (or even quantifiable) and we measure a biomarker instead. For example, pre-clinical and clinical investigations may use concentrations of proteins or counts of specific cell types from blood samples, such as the CD4+ cell count used as a biomarker for immune system function.

1.4.2 Internal Validity

The internal validity of an experiment concerns the soundness of the scientific rationale, statistical properties such as precision of estimates, and the measures taken against risk of bias. It refers to the validity of claims within the context of the experiment. Statistical design of experiments plays a prominent role in ensuring internal validity, and we briefly discuss the main ideas before providing the technical details and an application to our example in the subsequent sections.

Scientific Rationale and Research Question

The scientific rationale of a study is (usually) not immediately a statistical question. Translating a scientific question into a quantitative comparison amenable to statistical analysis is no small task and often requires careful consideration. It is a substantial, if non-statistical, benefit of using experimental design that we are forced to formulate a precise-enough research question and decide on the main analyses required for answering it before we conduct the experiment. For example, the question: is there a difference between placebo and drug? is insufficiently precise for planning a statistical analysis and determine an adequate experimental design. What exactly is the drug treatment? What should the drug’s concentration be and how is it administered? How do we make sure that the placebo group is comparable to the drug group in all other aspects? What do we measure and what do we mean by “difference?” A shift in average response, a fold-change, change in response before and after treatment?

The scientific rationale also enters the choice of a potential control group to which we compare responses. The quote

The deep, fundamental question in statistical analysis is ‘Compared to what?’ ( Tufte 1997 )

highlights the importance of this choice.

There are almost never enough resources to answer all relevant scientific questions. We therefore define a few questions of highest interest, and the main purpose of the experiment is answering these questions in the primary analysis . This intended analysis drives the experimental design to ensure relevant estimates can be calculated and have sufficient precision, and tests are adequately powered. This does not preclude us from conducting additional secondary analyses and exploratory analyses , but we are not willing to enlarge the experiment to ensure that strong conclusions can also be drawn from these analyses.

Risk of Bias

Experimental bias is a systematic difference in response between experimental units in addition to the difference caused by the treatments. The experimental units in the different groups are then not equal in all aspects other than the treatment applied to them. We saw several examples in Section 1.2 .

Minimizing the risk of bias is crucial for internal validity and we look at some common measures to eliminate or reduce different types of bias in Section 1.5 .

Precision and Effect Size

Another aspect of internal validity is the precision of estimates and the expected effect sizes. Is the experimental setup, in principle, able to detect a difference of relevant magnitude? Experimental design offers several methods for answering this question based on the expected heterogeneity of samples, the measurement error, and other sources of variation: power analysis is a technique for determining the number of samples required to reliably detect a relevant effect size and provide estimates of sufficient precision. More samples yield more precision and more power, but we have to be careful that replication is done at the right level: simply measuring a biological sample multiple times as in Figure 1.1 B yields more measured values, but is pseudo-replication for analyses. Replication should also ensure that the statistical uncertainties of estimates can be gauged from the data of the experiment itself, without additional untestable assumptions. Finally, the technique of blocking , shown in Figure 1.1 C, can remove a substantial proportion of the variation and thereby increase power and precision if we find a way to apply it.

1.4.3 External Validity

The external validity of an experiment concerns its replicability and the generalizability of inferences. An experiment is replicable if its results can be confirmed by an independent new experiment, preferably by a different lab and researcher. Experimental conditions in the replicate experiment usually differ from the original experiment, which provides evidence that the observed effects are robust to such changes. A much weaker condition on an experiment is reproducibility , the property that an independent researcher draws equivalent conclusions based on the data from this particular experiment, using the same analysis techniques. Reproducibility requires publishing the raw data, details on the experimental protocol, and a description of the statistical analyses, preferably with accompanying source code. Many scientific journals subscribe to reporting guidelines to ensure reproducibility and these are also helpful for planning an experiment.

A main threat to replicability and generalizability are too tightly controlled experimental conditions, when inferences only hold for a specific lab under the very specific conditions of the original experiment. Introducing systematic heterogeneity and using multi-center studies effectively broadens the experimental conditions and therefore the inferences for which internal validity is available.

For systematic heterogeneity , experimental conditions are systematically altered in addition to the treatments, and treatment differences estimated for each condition. For example, we might split the experimental material into several batches and use a different day of analysis, sample preparation, batch of buffer, measurement device, and lab technician for each batch. A more general inference is then possible if effect size, effect direction, and precision are comparable between the batches, indicating that the treatment differences are stable over the different conditions.

In multi-center experiments , the same experiment is conducted in several different labs and the results compared and merged. Multi-center approaches are very common in clinical trials and often necessary to reach the required number of patient enrollments.

Generalizability of randomized controlled trials in medicine and animal studies can suffer from overly restrictive eligibility criteria. In clinical trials, patients are often included or excluded based on co-medications and co-morbidities, and the resulting sample of eligible patients might no longer be representative of the patient population. For example, Travers et al. ( 2007 ) used the eligibility criteria of 17 random controlled trials of asthma treatments and found that out of 749 patients, only a median of 6% (45 patients) would be eligible for an asthma-related randomized controlled trial. This puts a question mark on the relevance of the trials’ findings for asthma patients in general.

1.5 Reducing the Risk of Bias

1.5.1 randomization of treatment allocation.

If systematic differences other than the treatment exist between our treatment groups, then the effect of the treatment is confounded with these other differences and our estimates of treatment effects might be biased.

We remove such unwanted systematic differences from our treatment comparisons by randomizing the allocation of treatments to experimental units. In a completely randomized design , each experimental unit has the same chance of being subjected to any of the treatments, and any differences between the experimental units other than the treatments are distributed over the treatment groups. Importantly, randomization is the only method that also protects our experiment against unknown sources of bias: we do not need to know all or even any of the potential differences and yet their impact is eliminated from the treatment comparisons by random treatment allocation.

Randomization has two effects: (i) differences unrelated to treatment become part of the ‘statistical noise’ rendering the treatment groups more similar; and (ii) the systematic differences are thereby eliminated as sources of bias from the treatment comparison.

Randomization transforms systematic variation into random variation.

In our example, a proper randomization would select 10 out of our 20 mice fully at random, such that the probability of any one mouse being picked is 1/20. These ten mice are then assigned to kit A, and the remaining mice to kit B. This allocation is entirely independent of the treatments and of any properties of the mice.

To ensure random treatment allocation, some kind of random process needs to be employed. This can be as simple as shuffling a pack of 10 red and 10 black cards or using a software-based random number generator. Randomization is slightly more difficult if the number of experimental units is not known at the start of the experiment, such as when patients are recruited for an ongoing clinical trial (sometimes called rolling recruitment ), and we want to have reasonable balance between the treatment groups at each stage of the trial.

Seemingly random assignments “by hand” are usually no less complicated than fully random assignments, but are always inferior. If surprising results ensue from the experiment, such assignments are subject to unanswerable criticism and suspicion of unwanted bias. Even worse are systematic allocations; they can only remove bias from known causes, and immediately raise red flags under the slightest scrutiny.

The Problem of Undesired Assignments

Even with a fully random treatment allocation procedure, we might end up with an undesirable allocation. For our example, the treatment group of kit A might—just by chance—contain mice that are all bigger or more active than those in the other treatment group. Statistical orthodoxy recommends using the design nevertheless, because only full randomization guarantees valid estimates of residual variance and unbiased estimates of effects. This argument, however, concerns the long-run properties of the procedure and seems of little help in this specific situation. Why should we care if the randomization yields correct estimates under replication of the experiment, if the particular experiment is jeopardized?

Another solution is to create a list of all possible allocations that we would accept and randomly choose one of these allocations for our experiment. The analysis should then reflect this restriction in the possible randomizations, which often renders this approach difficult to implement.

The most pragmatic method is to reject highly undesirable designs and compute a new randomization ( Cox 1958 ) . Undesirable allocations are unlikely to arise for large sample sizes, and we might accept a small bias in estimation for small sample sizes, when uncertainty in the estimated treatment effect is already high. In this approach, whenever we reject a particular outcome, we must also be willing to reject the outcome if we permute the treatment level labels. If we reject eight big and two small mice for kit A, then we must also reject two big and eight small mice. We must also be transparent and report a rejected allocation, so that critics may come to their own conclusions about potential biases and their remedies.

1.5.2 Blinding

Bias in treatment comparisons is also introduced if treatment allocation is random, but responses cannot be measured entirely objectively, or if knowledge of the assigned treatment affects the response. In clinical trials, for example, patients might react differently when they know to be on a placebo treatment, an effect known as cognitive bias . In animal experiments, caretakers might report more abnormal behavior for animals on a more severe treatment. Cognitive bias can be eliminated by concealing the treatment allocation from technicians or participants of a clinical trial, a technique called single-blinding .

If response measures are partially based on professional judgement (such as a clinical scale), patient or physician might unconsciously report lower scores for a placebo treatment, a phenomenon known as observer bias . Its removal requires double blinding , where treatment allocations are additionally concealed from the experimentalist.

Blinding requires randomized treatment allocation to begin with and substantial effort might be needed to implement it. Drug companies, for example, have to go to great lengths to ensure that a placebo looks, tastes, and feels similar enough to the actual drug. Additionally, blinding is often done by coding the treatment conditions and samples, and effect sizes and statistical significance are calculated before the code is revealed.

In clinical trials, double-blinding creates a conflict of interest. The attending physicians do not know which patient received which treatment, and thus accumulation of side-effects cannot be linked to any treatment. For this reason, clinical trials have a data monitoring committee not involved in the final analysis, that performs intermediate analyses of efficacy and safety at predefined intervals. If severe problems are detected, the committee might recommend altering or aborting the trial. The same might happen if one treatment already shows overwhelming evidence of superiority, such that it becomes unethical to withhold this treatment from the other patients.

1.5.3 Analysis Plan and Registration

An often overlooked source of bias has been termed the researcher degrees of freedom or garden of forking paths in the data analysis. For any set of data, there are many different options for its analysis: some results might be considered outliers and discarded, assumptions are made on error distributions and appropriate test statistics, different covariates might be included into a regression model. Often, multiple hypotheses are investigated and tested, and analyses are done separately on various (overlapping) subgroups. Hypotheses formed after looking at the data require additional care in their interpretation; almost never will \(p\) -values for these ad hoc or post hoc hypotheses be statistically justifiable. Many different measured response variables invite fishing expeditions , where patterns in the data are sought without an underlying hypothesis. Only reporting those sub-analyses that gave ‘interesting’ findings invariably leads to biased conclusions and is called cherry-picking or \(p\) -hacking (or much less flattering names).

The statistical analysis is always part of a larger scientific argument and we should consider the necessary computations in relation to building our scientific argument about the interpretation of the data. In addition to the statistical calculations, this interpretation requires substantial subject-matter knowledge and includes (many) non-statistical arguments. Two quotes highlight that experiment and analysis are a means to an end and not the end in itself.

There is a boundary in data interpretation beyond which formulas and quantitative decision procedures do not go, where judgment and style enter. ( Abelson 1995 )

Often, perfectly reasonable people come to perfectly reasonable decisions or conclusions based on nonstatistical evidence. Statistical analysis is a tool with which we support reasoning. It is not a goal in itself. ( Bailar III 1981 )

There is often a grey area between exploiting researcher degrees of freedom to arrive at a desired conclusion, and creative yet informed analyses of data. One way to navigate this area is to distinguish between exploratory studies and confirmatory studies . The former have no clearly stated scientific question, but are used to generate interesting hypotheses by identifying potential associations or effects that are then further investigated. Conclusions from these studies are very tentative and must be reported honestly as such. In contrast, standards are much higher for confirmatory studies, which investigate a specific predefined scientific question. Analysis plans and pre-registration of an experiment are accepted means for demonstrating lack of bias due to researcher degrees of freedom, and separating primary from secondary analyses allows emphasizing the main goals of the study.

Analysis Plan

The analysis plan is written before conducting the experiment and details the measurands and estimands, the hypotheses to be tested together with a power and sample size calculation, a discussion of relevant effect sizes, detection and handling of outliers and missing data, as well as steps for data normalization such as transformations and baseline corrections. If a regression model is required, its factors and covariates are outlined. Particularly in biology, handling measurements below the limit of quantification and saturation effects require careful consideration.

In the context of clinical trials, the problem of estimands has become a recent focus of attention. An estimand is the target of a statistical estimation procedure, for example the true average difference in enzyme levels between the two preparation kits. A main problem in many studies are post-randomization events that can change the estimand, even if the estimation procedure remains the same. For example, if kit B fails to produce usable samples for measurement in five out of ten cases because the enzyme level was too low, while kit A could handle these enzyme levels perfectly fine, then this might severely exaggerate the observed difference between the two kits. Similar problems arise in drug trials, when some patients stop taking one of the drugs due to side-effects or other complications.

Registration

Registration of experiments is an even more severe measure used in conjunction with an analysis plan and is becoming standard in clinical trials. Here, information about the trial, including the analysis plan, procedure to recruit patients, and stopping criteria, are registered in a public database. Publications based on the trial then refer to this registration, such that reviewers and readers can compare what the researchers intended to do and what they actually did. Similar portals for pre-clinical and translational research are also available.

1.6 Notes and Summary

The problem of measurements and measurands is further discussed for statistics in Hand ( 1996 ) and specifically for biological experiments in Coxon, Longstaff, and Burns ( 2019 ) . A general review of methods for handling missing data is Dong and Peng ( 2013 ) . The different roles of randomization are emphasized in Cox ( 2009 ) .

Two well-known reporting guidelines are the ARRIVE guidelines for animal research ( Kilkenny et al. 2010 ) and the CONSORT guidelines for clinical trials ( Moher et al. 2010 ) . Guidelines describing the minimal information required for reproducing experimental results have been developed for many types of experimental techniques, including microarrays (MIAME), RNA sequencing (MINSEQE), metabolomics (MSI) and proteomics (MIAPE) experiments; the FAIRSHARE initiative provides a more comprehensive collection ( Sansone et al. 2019 ) .

The problems of experimental design in animal experiments and particularly translation research are discussed in Couzin-Frankel ( 2013 ) . Multi-center studies are now considered for these investigations, and using a second laboratory already increases reproducibility substantially ( Richter et al. 2010 ; Richter 2017 ; Voelkl et al. 2018 ; Karp 2018 ) and allows standardizing the treatment effects ( Kafkafi et al. 2017 ) . First attempts are reported of using designs similar to clinical trials ( Llovera and Liesz 2016 ) . Exploratory-confirmatory research and external validity for animal studies is discussed in Kimmelman, Mogil, and Dirnagl ( 2014 ) and Pound and Ritskes-Hoitinga ( 2018 ) . Further information on pilot studies is found in Moore et al. ( 2011 ) , Sim ( 2019 ) , and Thabane et al. ( 2010 ) .

The deliberate use of statistical analyses and their interpretation for supporting a larger argument was called statistics as principled argument ( Abelson 1995 ) . Employing useless statistical analysis without reference to the actual scientific question is surrogate science ( Gigerenzer and Marewski 2014 ) and adaptive thinking is integral to meaningful statistical analysis ( Gigerenzer 2002 ) .

In an experiment, the investigator has full control over the experimental conditions applied to the experiment material. The experimental design gives the logical structure of an experiment: the units describing the organization of the experimental material, the treatments and their allocation to units, and the response. Statistical design of experiments includes techniques to ensure internal validity of an experiment, and methods to make inference from experimental data efficient.

Want to create or adapt books like this? Learn more about how Pressbooks supports open publishing practices.

10 Experimental research

Experimental research—often considered to be the ‘gold standard’ in research designs—is one of the most rigorous of all research designs. In this design, one or more independent variables are manipulated by the researcher (as treatments), subjects are randomly assigned to different treatment levels (random assignment), and the results of the treatments on outcomes (dependent variables) are observed. The unique strength of experimental research is its internal validity (causality) due to its ability to link cause and effect through treatment manipulation, while controlling for the spurious effect of extraneous variable.

Experimental research is best suited for explanatory research—rather than for descriptive or exploratory research—where the goal of the study is to examine cause-effect relationships. It also works well for research that involves a relatively limited and well-defined set of independent variables that can either be manipulated or controlled. Experimental research can be conducted in laboratory or field settings. Laboratory experiments , conducted in laboratory (artificial) settings, tend to be high in internal validity, but this comes at the cost of low external validity (generalisability), because the artificial (laboratory) setting in which the study is conducted may not reflect the real world. Field experiments are conducted in field settings such as in a real organisation, and are high in both internal and external validity. But such experiments are relatively rare, because of the difficulties associated with manipulating treatments and controlling for extraneous effects in a field setting.

Experimental research can be grouped into two broad categories: true experimental designs and quasi-experimental designs. Both designs require treatment manipulation, but while true experiments also require random assignment, quasi-experiments do not. Sometimes, we also refer to non-experimental research, which is not really a research design, but an all-inclusive term that includes all types of research that do not employ treatment manipulation or random assignment, such as survey research, observational research, and correlational studies.

Basic concepts

Treatment and control groups. In experimental research, some subjects are administered one or more experimental stimulus called a treatment (the treatment group ) while other subjects are not given such a stimulus (the control group ). The treatment may be considered successful if subjects in the treatment group rate more favourably on outcome variables than control group subjects. Multiple levels of experimental stimulus may be administered, in which case, there may be more than one treatment group. For example, in order to test the effects of a new drug intended to treat a certain medical condition like dementia, if a sample of dementia patients is randomly divided into three groups, with the first group receiving a high dosage of the drug, the second group receiving a low dosage, and the third group receiving a placebo such as a sugar pill (control group), then the first two groups are experimental groups and the third group is a control group. After administering the drug for a period of time, if the condition of the experimental group subjects improved significantly more than the control group subjects, we can say that the drug is effective. We can also compare the conditions of the high and low dosage experimental groups to determine if the high dose is more effective than the low dose.

Treatment manipulation. Treatments are the unique feature of experimental research that sets this design apart from all other research methods. Treatment manipulation helps control for the ‘cause’ in cause-effect relationships. Naturally, the validity of experimental research depends on how well the treatment was manipulated. Treatment manipulation must be checked using pretests and pilot tests prior to the experimental study. Any measurements conducted before the treatment is administered are called pretest measures , while those conducted after the treatment are posttest measures .

Random selection and assignment. Random selection is the process of randomly drawing a sample from a population or a sampling frame. This approach is typically employed in survey research, and ensures that each unit in the population has a positive chance of being selected into the sample. Random assignment, however, is a process of randomly assigning subjects to experimental or control groups. This is a standard practice in true experimental research to ensure that treatment groups are similar (equivalent) to each other and to the control group prior to treatment administration. Random selection is related to sampling, and is therefore more closely related to the external validity (generalisability) of findings. However, random assignment is related to design, and is therefore most related to internal validity. It is possible to have both random selection and random assignment in well-designed experimental research, but quasi-experimental research involves neither random selection nor random assignment.

Threats to internal validity. Although experimental designs are considered more rigorous than other research methods in terms of the internal validity of their inferences (by virtue of their ability to control causes through treatment manipulation), they are not immune to internal validity threats. Some of these threats to internal validity are described below, within the context of a study of the impact of a special remedial math tutoring program for improving the math abilities of high school students.

History threat is the possibility that the observed effects (dependent variables) are caused by extraneous or historical events rather than by the experimental treatment. For instance, students’ post-remedial math score improvement may have been caused by their preparation for a math exam at their school, rather than the remedial math program.

Maturation threat refers to the possibility that observed effects are caused by natural maturation of subjects (e.g., a general improvement in their intellectual ability to understand complex concepts) rather than the experimental treatment.

Testing threat is a threat in pre-post designs where subjects’ posttest responses are conditioned by their pretest responses. For instance, if students remember their answers from the pretest evaluation, they may tend to repeat them in the posttest exam.

Not conducting a pretest can help avoid this threat.

Instrumentation threat , which also occurs in pre-post designs, refers to the possibility that the difference between pretest and posttest scores is not due to the remedial math program, but due to changes in the administered test, such as the posttest having a higher or lower degree of difficulty than the pretest.

Mortality threat refers to the possibility that subjects may be dropping out of the study at differential rates between the treatment and control groups due to a systematic reason, such that the dropouts were mostly students who scored low on the pretest. If the low-performing students drop out, the results of the posttest will be artificially inflated by the preponderance of high-performing students.

Regression threat —also called a regression to the mean—refers to the statistical tendency of a group’s overall performance to regress toward the mean during a posttest rather than in the anticipated direction. For instance, if subjects scored high on a pretest, they will have a tendency to score lower on the posttest (closer to the mean) because their high scores (away from the mean) during the pretest were possibly a statistical aberration. This problem tends to be more prevalent in non-random samples and when the two measures are imperfectly correlated.

Two-group experimental designs

Pretest-posttest control group design . In this design, subjects are randomly assigned to treatment and control groups, subjected to an initial (pretest) measurement of the dependent variables of interest, the treatment group is administered a treatment (representing the independent variable of interest), and the dependent variables measured again (posttest). The notation of this design is shown in Figure 10.1.

Statistical analysis of this design involves a simple analysis of variance (ANOVA) between the treatment and control groups. The pretest-posttest design handles several threats to internal validity, such as maturation, testing, and regression, since these threats can be expected to influence both treatment and control groups in a similar (random) manner. The selection threat is controlled via random assignment. However, additional threats to internal validity may exist. For instance, mortality can be a problem if there are differential dropout rates between the two groups, and the pretest measurement may bias the posttest measurement—especially if the pretest introduces unusual topics or content.

Posttest -only control group design . This design is a simpler version of the pretest-posttest design where pretest measurements are omitted. The design notation is shown in Figure 10.2.

The treatment effect is measured simply as the difference in the posttest scores between the two groups:

The appropriate statistical analysis of this design is also a two-group analysis of variance (ANOVA). The simplicity of this design makes it more attractive than the pretest-posttest design in terms of internal validity. This design controls for maturation, testing, regression, selection, and pretest-posttest interaction, though the mortality threat may continue to exist.

Because the pretest measure is not a measurement of the dependent variable, but rather a covariate, the treatment effect is measured as the difference in the posttest scores between the treatment and control groups as:

Due to the presence of covariates, the right statistical analysis of this design is a two-group analysis of covariance (ANCOVA). This design has all the advantages of posttest-only design, but with internal validity due to the controlling of covariates. Covariance designs can also be extended to pretest-posttest control group design.

Factorial designs

Two-group designs are inadequate if your research requires manipulation of two or more independent variables (treatments). In such cases, you would need four or higher-group designs. Such designs, quite popular in experimental research, are commonly called factorial designs. Each independent variable in this design is called a factor , and each subdivision of a factor is called a level . Factorial designs enable the researcher to examine not only the individual effect of each treatment on the dependent variables (called main effects), but also their joint effect (called interaction effects).

In a factorial design, a main effect is said to exist if the dependent variable shows a significant difference between multiple levels of one factor, at all levels of other factors. No change in the dependent variable across factor levels is the null case (baseline), from which main effects are evaluated. In the above example, you may see a main effect of instructional type, instructional time, or both on learning outcomes. An interaction effect exists when the effect of differences in one factor depends upon the level of a second factor. In our example, if the effect of instructional type on learning outcomes is greater for three hours/week of instructional time than for one and a half hours/week, then we can say that there is an interaction effect between instructional type and instructional time on learning outcomes. Note that the presence of interaction effects dominate and make main effects irrelevant, and it is not meaningful to interpret main effects if interaction effects are significant.

Hybrid experimental designs

Hybrid designs are those that are formed by combining features of more established designs. Three such hybrid designs are randomised bocks design, Solomon four-group design, and switched replications design.

Randomised block design. This is a variation of the posttest-only or pretest-posttest control group design where the subject population can be grouped into relatively homogeneous subgroups (called blocks ) within which the experiment is replicated. For instance, if you want to replicate the same posttest-only design among university students and full-time working professionals (two homogeneous blocks), subjects in both blocks are randomly split between the treatment group (receiving the same treatment) and the control group (see Figure 10.5). The purpose of this design is to reduce the ‘noise’ or variance in data that may be attributable to differences between the blocks so that the actual effect of interest can be detected more accurately.

Solomon four-group design . In this design, the sample is divided into two treatment groups and two control groups. One treatment group and one control group receive the pretest, and the other two groups do not. This design represents a combination of posttest-only and pretest-posttest control group design, and is intended to test for the potential biasing effect of pretest measurement on posttest measures that tends to occur in pretest-posttest designs, but not in posttest-only designs. The design notation is shown in Figure 10.6.

Switched replication design . This is a two-group design implemented in two phases with three waves of measurement. The treatment group in the first phase serves as the control group in the second phase, and the control group in the first phase becomes the treatment group in the second phase, as illustrated in Figure 10.7. In other words, the original design is repeated or replicated temporally with treatment/control roles switched between the two groups. By the end of the study, all participants will have received the treatment either during the first or the second phase. This design is most feasible in organisational contexts where organisational programs (e.g., employee training) are implemented in a phased manner or are repeated at regular intervals.

Quasi-experimental designs

Quasi-experimental designs are almost identical to true experimental designs, but lacking one key ingredient: random assignment. For instance, one entire class section or one organisation is used as the treatment group, while another section of the same class or a different organisation in the same industry is used as the control group. This lack of random assignment potentially results in groups that are non-equivalent, such as one group possessing greater mastery of certain content than the other group, say by virtue of having a better teacher in a previous semester, which introduces the possibility of selection bias . Quasi-experimental designs are therefore inferior to true experimental designs in interval validity due to the presence of a variety of selection related threats such as selection-maturation threat (the treatment and control groups maturing at different rates), selection-history threat (the treatment and control groups being differentially impacted by extraneous or historical events), selection-regression threat (the treatment and control groups regressing toward the mean between pretest and posttest at different rates), selection-instrumentation threat (the treatment and control groups responding differently to the measurement), selection-testing (the treatment and control groups responding differently to the pretest), and selection-mortality (the treatment and control groups demonstrating differential dropout rates). Given these selection threats, it is generally preferable to avoid quasi-experimental designs to the greatest extent possible.

In addition, there are quite a few unique non-equivalent designs without corresponding true experimental design cousins. Some of the more useful of these designs are discussed next.

Regression discontinuity (RD) design . This is a non-equivalent pretest-posttest design where subjects are assigned to the treatment or control group based on a cut-off score on a preprogram measure. For instance, patients who are severely ill may be assigned to a treatment group to test the efficacy of a new drug or treatment protocol and those who are mildly ill are assigned to the control group. In another example, students who are lagging behind on standardised test scores may be selected for a remedial curriculum program intended to improve their performance, while those who score high on such tests are not selected from the remedial program.

Because of the use of a cut-off score, it is possible that the observed results may be a function of the cut-off score rather than the treatment, which introduces a new threat to internal validity. However, using the cut-off score also ensures that limited or costly resources are distributed to people who need them the most, rather than randomly across a population, while simultaneously allowing a quasi-experimental treatment. The control group scores in the RD design do not serve as a benchmark for comparing treatment group scores, given the systematic non-equivalence between the two groups. Rather, if there is no discontinuity between pretest and posttest scores in the control group, but such a discontinuity persists in the treatment group, then this discontinuity is viewed as evidence of the treatment effect.

Proxy pretest design . This design, shown in Figure 10.11, looks very similar to the standard NEGD (pretest-posttest) design, with one critical difference: the pretest score is collected after the treatment is administered. A typical application of this design is when a researcher is brought in to test the efficacy of a program (e.g., an educational program) after the program has already started and pretest data is not available. Under such circumstances, the best option for the researcher is often to use a different prerecorded measure, such as students’ grade point average before the start of the program, as a proxy for pretest data. A variation of the proxy pretest design is to use subjects’ posttest recollection of pretest data, which may be subject to recall bias, but nevertheless may provide a measure of perceived gain or change in the dependent variable.

Separate pretest-posttest samples design . This design is useful if it is not possible to collect pretest and posttest data from the same subjects for some reason. As shown in Figure 10.12, there are four groups in this design, but two groups come from a single non-equivalent group, while the other two groups come from a different non-equivalent group. For instance, say you want to test customer satisfaction with a new online service that is implemented in one city but not in another. In this case, customers in the first city serve as the treatment group and those in the second city constitute the control group. If it is not possible to obtain pretest and posttest measures from the same customers, you can measure customer satisfaction at one point in time, implement the new service program, and measure customer satisfaction (with a different set of customers) after the program is implemented. Customer satisfaction is also measured in the control group at the same times as in the treatment group, but without the new program implementation. The design is not particularly strong, because you cannot examine the changes in any specific customer’s satisfaction score before and after the implementation, but you can only examine average customer satisfaction scores. Despite the lower internal validity, this design may still be a useful way of collecting quasi-experimental data when pretest and posttest data is not available from the same subjects.

An interesting variation of the NEDV design is a pattern-matching NEDV design , which employs multiple outcome variables and a theory that explains how much each variable will be affected by the treatment. The researcher can then examine if the theoretical prediction is matched in actual observations. This pattern-matching technique—based on the degree of correspondence between theoretical and observed patterns—is a powerful way of alleviating internal validity concerns in the original NEDV design.

Perils of experimental research

Experimental research is one of the most difficult of research designs, and should not be taken lightly. This type of research is often best with a multitude of methodological problems. First, though experimental research requires theories for framing hypotheses for testing, much of current experimental research is atheoretical. Without theories, the hypotheses being tested tend to be ad hoc, possibly illogical, and meaningless. Second, many of the measurement instruments used in experimental research are not tested for reliability and validity, and are incomparable across studies. Consequently, results generated using such instruments are also incomparable. Third, often experimental research uses inappropriate research designs, such as irrelevant dependent variables, no interaction effects, no experimental controls, and non-equivalent stimulus across treatment groups. Findings from such studies tend to lack internal validity and are highly suspect. Fourth, the treatments (tasks) used in experimental research may be diverse, incomparable, and inconsistent across studies, and sometimes inappropriate for the subject population. For instance, undergraduate student subjects are often asked to pretend that they are marketing managers and asked to perform a complex budget allocation task in which they have no experience or expertise. The use of such inappropriate tasks, introduces new threats to internal validity (i.e., subject’s performance may be an artefact of the content or difficulty of the task setting), generates findings that are non-interpretable and meaningless, and makes integration of findings across studies impossible.

The design of proper experimental treatments is a very important task in experimental design, because the treatment is the raison d’etre of the experimental method, and must never be rushed or neglected. To design an adequate and appropriate task, researchers should use prevalidated tasks if available, conduct treatment manipulation checks to check for the adequacy of such tasks (by debriefing subjects after performing the assigned task), conduct pilot tests (repeatedly, if necessary), and if in doubt, use tasks that are simple and familiar for the respondent sample rather than tasks that are complex or unfamiliar.

In summary, this chapter introduced key concepts in the experimental design research method and introduced a variety of true experimental and quasi-experimental designs. Although these designs vary widely in internal validity, designs with less internal validity should not be overlooked and may sometimes be useful under specific circumstances and empirical contingencies.

Social Science Research: Principles, Methods and Practices (Revised edition) Copyright © 2019 by Anol Bhattacherjee is licensed under a Creative Commons Attribution-NonCommercial-ShareAlike 4.0 International License , except where otherwise noted.

Share This Book

19+ Experimental Design Examples (Methods + Types)

Ever wondered how scientists discover new medicines, psychologists learn about behavior, or even how marketers figure out what kind of ads you like? Well, they all have something in common: they use a special plan or recipe called an "experimental design."

Imagine you're baking cookies. You can't just throw random amounts of flour, sugar, and chocolate chips into a bowl and hope for the best. You follow a recipe, right? Scientists and researchers do something similar. They follow a "recipe" called an experimental design to make sure their experiments are set up in a way that the answers they find are meaningful and reliable.

Experimental design is the roadmap researchers use to answer questions. It's a set of rules and steps that researchers follow to collect information, or "data," in a way that is fair, accurate, and makes sense.

Long ago, people didn't have detailed game plans for experiments. They often just tried things out and saw what happened. But over time, people got smarter about this. They started creating structured plans—what we now call experimental designs—to get clearer, more trustworthy answers to their questions.

In this article, we'll take you on a journey through the world of experimental designs. We'll talk about the different types, or "flavors," of experimental designs, where they're used, and even give you a peek into how they came to be.

What Is Experimental Design?

Alright, before we dive into the different types of experimental designs, let's get crystal clear on what experimental design actually is.

Imagine you're a detective trying to solve a mystery. You need clues, right? Well, in the world of research, experimental design is like the roadmap that helps you find those clues. It's like the game plan in sports or the blueprint when you're building a house. Just like you wouldn't start building without a good blueprint, researchers won't start their studies without a strong experimental design.

So, why do we need experimental design? Think about baking a cake. If you toss ingredients into a bowl without measuring, you'll end up with a mess instead of a tasty dessert.

Similarly, in research, if you don't have a solid plan, you might get confusing or incorrect results. A good experimental design helps you ask the right questions ( think critically ), decide what to measure ( come up with an idea ), and figure out how to measure it (test it). It also helps you consider things that might mess up your results, like outside influences you hadn't thought of.

For example, let's say you want to find out if listening to music helps people focus better. Your experimental design would help you decide things like: Who are you going to test? What kind of music will you use? How will you measure focus? And, importantly, how will you make sure that it's really the music affecting focus and not something else, like the time of day or whether someone had a good breakfast?

In short, experimental design is the master plan that guides researchers through the process of collecting data, so they can answer questions in the most reliable way possible. It's like the GPS for the journey of discovery!

History of Experimental Design

Around 350 BCE, people like Aristotle were trying to figure out how the world works, but they mostly just thought really hard about things. They didn't test their ideas much. So while they were super smart, their methods weren't always the best for finding out the truth.

Fast forward to the Renaissance (14th to 17th centuries), a time of big changes and lots of curiosity. People like Galileo started to experiment by actually doing tests, like rolling balls down inclined planes to study motion. Galileo's work was cool because he combined thinking with doing. He'd have an idea, test it, look at the results, and then think some more. This approach was a lot more reliable than just sitting around and thinking.

Now, let's zoom ahead to the 18th and 19th centuries. This is when people like Francis Galton, an English polymath, started to get really systematic about experimentation. Galton was obsessed with measuring things. Seriously, he even tried to measure how good-looking people were ! His work helped create the foundations for a more organized approach to experiments.

Next stop: the early 20th century. Enter Ronald A. Fisher , a brilliant British statistician. Fisher was a game-changer. He came up with ideas that are like the bread and butter of modern experimental design.

Fisher invented the concept of the " control group "—that's a group of people or things that don't get the treatment you're testing, so you can compare them to those who do. He also stressed the importance of " randomization ," which means assigning people or things to different groups by chance, like drawing names out of a hat. This makes sure the experiment is fair and the results are trustworthy.

Around the same time, American psychologists like John B. Watson and B.F. Skinner were developing " behaviorism ." They focused on studying things that they could directly observe and measure, like actions and reactions.

Skinner even built boxes—called Skinner Boxes —to test how animals like pigeons and rats learn. Their work helped shape how psychologists design experiments today. Watson performed a very controversial experiment called The Little Albert experiment that helped describe behaviour through conditioning—in other words, how people learn to behave the way they do.

In the later part of the 20th century and into our time, computers have totally shaken things up. Researchers now use super powerful software to help design their experiments and crunch the numbers.

With computers, they can simulate complex experiments before they even start, which helps them predict what might happen. This is especially helpful in fields like medicine, where getting things right can be a matter of life and death.

Also, did you know that experimental designs aren't just for scientists in labs? They're used by people in all sorts of jobs, like marketing, education, and even video game design! Yes, someone probably ran an experiment to figure out what makes a game super fun to play.

So there you have it—a quick tour through the history of experimental design, from Aristotle's deep thoughts to Fisher's groundbreaking ideas, and all the way to today's computer-powered research. These designs are the recipes that help people from all walks of life find answers to their big questions.

Key Terms in Experimental Design

Before we dig into the different types of experimental designs, let's get comfy with some key terms. Understanding these terms will make it easier for us to explore the various types of experimental designs that researchers use to answer their big questions.

Independent Variable : This is what you change or control in your experiment to see what effect it has. Think of it as the "cause" in a cause-and-effect relationship. For example, if you're studying whether different types of music help people focus, the kind of music is the independent variable.

Dependent Variable : This is what you're measuring to see the effect of your independent variable. In our music and focus experiment, how well people focus is the dependent variable—it's what "depends" on the kind of music played.

Control Group : This is a group of people who don't get the special treatment or change you're testing. They help you see what happens when the independent variable is not applied. If you're testing whether a new medicine works, the control group would take a fake pill, called a placebo , instead of the real medicine.

Experimental Group : This is the group that gets the special treatment or change you're interested in. Going back to our medicine example, this group would get the actual medicine to see if it has any effect.

Randomization : This is like shaking things up in a fair way. You randomly put people into the control or experimental group so that each group is a good mix of different kinds of people. This helps make the results more reliable.

Sample : This is the group of people you're studying. They're a "sample" of a larger group that you're interested in. For instance, if you want to know how teenagers feel about a new video game, you might study a sample of 100 teenagers.

Bias : This is anything that might tilt your experiment one way or another without you realizing it. Like if you're testing a new kind of dog food and you only test it on poodles, that could create a bias because maybe poodles just really like that food and other breeds don't.

Data : This is the information you collect during the experiment. It's like the treasure you find on your journey of discovery!

Replication : This means doing the experiment more than once to make sure your findings hold up. It's like double-checking your answers on a test.

Hypothesis : This is your educated guess about what will happen in the experiment. It's like predicting the end of a movie based on the first half.

Steps of Experimental Design

Alright, let's say you're all fired up and ready to run your own experiment. Cool! But where do you start? Well, designing an experiment is a bit like planning a road trip. There are some key steps you've got to take to make sure you reach your destination. Let's break it down:

• Ask a Question : Before you hit the road, you've got to know where you're going. Same with experiments. You start with a question you want to answer, like "Does eating breakfast really make you do better in school?"
• Do Some Homework : Before you pack your bags, you look up the best places to visit, right? In science, this means reading up on what other people have already discovered about your topic.
• Form a Hypothesis : This is your educated guess about what you think will happen. It's like saying, "I bet this route will get us there faster."
• Plan the Details : Now you decide what kind of car you're driving (your experimental design), who's coming with you (your sample), and what snacks to bring (your variables).
• Randomization : Remember, this is like shuffling a deck of cards. You want to mix up who goes into your control and experimental groups to make sure it's a fair test.
• Run the Experiment : Finally, the rubber hits the road! You carry out your plan, making sure to collect your data carefully.
• Analyze the Data : Once the trip's over, you look at your photos and decide which ones are keepers. In science, this means looking at your data to see what it tells you.
• Draw Conclusions : Based on your data, did you find an answer to your question? This is like saying, "Yep, that route was faster," or "Nope, we hit a ton of traffic."
• Share Your Findings : After a great trip, you want to tell everyone about it, right? Scientists do the same by publishing their results so others can learn from them.
• Do It Again? : Sometimes one road trip just isn't enough. In the same way, scientists often repeat their experiments to make sure their findings are solid.

So there you have it! Those are the basic steps you need to follow when you're designing an experiment. Each step helps make sure that you're setting up a fair and reliable way to find answers to your big questions.

Let's get into examples of experimental designs.

1) True Experimental Design

In the world of experiments, the True Experimental Design is like the superstar quarterback everyone talks about. Born out of the early 20th-century work of statisticians like Ronald A. Fisher, this design is all about control, precision, and reliability.

Researchers carefully pick an independent variable to manipulate (remember, that's the thing they're changing on purpose) and measure the dependent variable (the effect they're studying). Then comes the magic trick—randomization. By randomly putting participants into either the control or experimental group, scientists make sure their experiment is as fair as possible.

No sneaky biases here!

True Experimental Design Pros

The pros of True Experimental Design are like the perks of a VIP ticket at a concert: you get the best and most trustworthy results. Because everything is controlled and randomized, you can feel pretty confident that the results aren't just a fluke.

True Experimental Design Cons

However, there's a catch. Sometimes, it's really tough to set up these experiments in a real-world situation. Imagine trying to control every single detail of your day, from the food you eat to the air you breathe. Not so easy, right?

True Experimental Design Uses

The fields that get the most out of True Experimental Designs are those that need super reliable results, like medical research.

When scientists were developing COVID-19 vaccines, they used this design to run clinical trials. They had control groups that received a placebo (a harmless substance with no effect) and experimental groups that got the actual vaccine. Then they measured how many people in each group got sick. By comparing the two, they could say, "Yep, this vaccine works!"

So next time you read about a groundbreaking discovery in medicine or technology, chances are a True Experimental Design was the VIP behind the scenes, making sure everything was on point. It's been the go-to for rigorous scientific inquiry for nearly a century, and it's not stepping off the stage anytime soon.

2) Quasi-Experimental Design

So, let's talk about the Quasi-Experimental Design. Think of this one as the cool cousin of True Experimental Design. It wants to be just like its famous relative, but it's a bit more laid-back and flexible. You'll find quasi-experimental designs when it's tricky to set up a full-blown True Experimental Design with all the bells and whistles.

Quasi-experiments still play with an independent variable, just like their stricter cousins. The big difference? They don't use randomization. It's like wanting to divide a bag of jelly beans equally between your friends, but you can't quite do it perfectly.

In real life, it's often not possible or ethical to randomly assign people to different groups, especially when dealing with sensitive topics like education or social issues. And that's where quasi-experiments come in.

Quasi-Experimental Design Pros

Even though they lack full randomization, quasi-experimental designs are like the Swiss Army knives of research: versatile and practical. They're especially popular in fields like education, sociology, and public policy.

For instance, when researchers wanted to figure out if the Head Start program , aimed at giving young kids a "head start" in school, was effective, they used a quasi-experimental design. They couldn't randomly assign kids to go or not go to preschool, but they could compare kids who did with kids who didn't.

Quasi-Experimental Design Cons

Of course, quasi-experiments come with their own bag of pros and cons. On the plus side, they're easier to set up and often cheaper than true experiments. But the flip side is that they're not as rock-solid in their conclusions. Because the groups aren't randomly assigned, there's always that little voice saying, "Hey, are we missing something here?"

Quasi-Experimental Design Uses

Quasi-Experimental Design gained traction in the mid-20th century. Researchers were grappling with real-world problems that didn't fit neatly into a laboratory setting. Plus, as society became more aware of ethical considerations, the need for flexible designs increased. So, the quasi-experimental approach was like a breath of fresh air for scientists wanting to study complex issues without a laundry list of restrictions.

In short, if True Experimental Design is the superstar quarterback, Quasi-Experimental Design is the versatile player who can adapt and still make significant contributions to the game.

3) Pre-Experimental Design

Now, let's talk about the Pre-Experimental Design. Imagine it as the beginner's skateboard you get before you try out for all the cool tricks. It has wheels, it rolls, but it's not built for the professional skatepark.

Similarly, pre-experimental designs give researchers a starting point. They let you dip your toes in the water of scientific research without diving in head-first.

So, what's the deal with pre-experimental designs?

Pre-Experimental Designs are the basic, no-frills versions of experiments. Researchers still mess around with an independent variable and measure a dependent variable, but they skip over the whole randomization thing and often don't even have a control group.

It's like baking a cake but forgetting the frosting and sprinkles; you'll get some results, but they might not be as complete or reliable as you'd like.

Pre-Experimental Design Pros

Why use such a simple setup? Because sometimes, you just need to get the ball rolling. Pre-experimental designs are great for quick-and-dirty research when you're short on time or resources. They give you a rough idea of what's happening, which you can use to plan more detailed studies later.

A good example of this is early studies on the effects of screen time on kids. Researchers couldn't control every aspect of a child's life, but they could easily ask parents to track how much time their kids spent in front of screens and then look for trends in behavior or school performance.

Pre-Experimental Design Cons

But here's the catch: pre-experimental designs are like that first draft of an essay. It helps you get your ideas down, but you wouldn't want to turn it in for a grade. Because these designs lack the rigorous structure of true or quasi-experimental setups, they can't give you rock-solid conclusions. They're more like clues or signposts pointing you in a certain direction.

Pre-Experimental Design Uses

This type of design became popular in the early stages of various scientific fields. Researchers used them to scratch the surface of a topic, generate some initial data, and then decide if it's worth exploring further. In other words, pre-experimental designs were the stepping stones that led to more complex, thorough investigations.

So, while Pre-Experimental Design may not be the star player on the team, it's like the practice squad that helps everyone get better. It's the starting point that can lead to bigger and better things.

4) Factorial Design

Now, buckle up, because we're moving into the world of Factorial Design, the multi-tasker of the experimental universe.

Imagine juggling not just one, but multiple balls in the air—that's what researchers do in a factorial design.

In Factorial Design, researchers are not satisfied with just studying one independent variable. Nope, they want to study two or more at the same time to see how they interact.

It's like cooking with several spices to see how they blend together to create unique flavors.

Factorial Design became the talk of the town with the rise of computers. Why? Because this design produces a lot of data, and computers are the number crunchers that help make sense of it all. So, thanks to our silicon friends, researchers can study complicated questions like, "How do diet AND exercise together affect weight loss?" instead of looking at just one of those factors.

Factorial Design Pros

This design's main selling point is its ability to explore interactions between variables. For instance, maybe a new study drug works really well for young people but not so great for older adults. A factorial design could reveal that age is a crucial factor, something you might miss if you only studied the drug's effectiveness in general. It's like being a detective who looks for clues not just in one room but throughout the entire house.

Factorial Design Cons

However, factorial designs have their own bag of challenges. First off, they can be pretty complicated to set up and run. Imagine coordinating a four-way intersection with lots of cars coming from all directions—you've got to make sure everything runs smoothly, or you'll end up with a traffic jam. Similarly, researchers need to carefully plan how they'll measure and analyze all the different variables.

Factorial Design Uses

Factorial designs are widely used in psychology to untangle the web of factors that influence human behavior. They're also popular in fields like marketing, where companies want to understand how different aspects like price, packaging, and advertising influence a product's success.

And speaking of success, the factorial design has been a hit since statisticians like Ronald A. Fisher (yep, him again!) expanded on it in the early-to-mid 20th century. It offered a more nuanced way of understanding the world, proving that sometimes, to get the full picture, you've got to juggle more than one ball at a time.

So, if True Experimental Design is the quarterback and Quasi-Experimental Design is the versatile player, Factorial Design is the strategist who sees the entire game board and makes moves accordingly.

5) Longitudinal Design

Alright, let's take a step into the world of Longitudinal Design. Picture it as the grand storyteller, the kind who doesn't just tell you about a single event but spins an epic tale that stretches over years or even decades. This design isn't about quick snapshots; it's about capturing the whole movie of someone's life or a long-running process.

You know how you might take a photo every year on your birthday to see how you've changed? Longitudinal Design is kind of like that, but for scientific research.

With Longitudinal Design, instead of measuring something just once, researchers come back again and again, sometimes over many years, to see how things are going. This helps them understand not just what's happening, but why it's happening and how it changes over time.

This design really started to shine in the latter half of the 20th century, when researchers began to realize that some questions can't be answered in a hurry. Think about studies that look at how kids grow up, or research on how a certain medicine affects you over a long period. These aren't things you can rush.

The famous Framingham Heart Study , started in 1948, is a prime example. It's been studying heart health in a small town in Massachusetts for decades, and the findings have shaped what we know about heart disease.

Longitudinal Design Pros

So, what's to love about Longitudinal Design? First off, it's the go-to for studying change over time, whether that's how people age or how a forest recovers from a fire.

Longitudinal Design Cons

But it's not all sunshine and rainbows. Longitudinal studies take a lot of patience and resources. Plus, keeping track of participants over many years can be like herding cats—difficult and full of surprises.

Longitudinal Design Uses

Despite these challenges, longitudinal studies have been key in fields like psychology, sociology, and medicine. They provide the kind of deep, long-term insights that other designs just can't match.

So, if the True Experimental Design is the superstar quarterback, and the Quasi-Experimental Design is the flexible athlete, then the Factorial Design is the strategist, and the Longitudinal Design is the wise elder who has seen it all and has stories to tell.

6) Cross-Sectional Design

Now, let's flip the script and talk about Cross-Sectional Design, the polar opposite of the Longitudinal Design. If Longitudinal is the grand storyteller, think of Cross-Sectional as the snapshot photographer. It captures a single moment in time, like a selfie that you take to remember a fun day. Researchers using this design collect all their data at one point, providing a kind of "snapshot" of whatever they're studying.

In a Cross-Sectional Design, researchers look at multiple groups all at the same time to see how they're different or similar.

This design rose to popularity in the mid-20th century, mainly because it's so quick and efficient. Imagine wanting to know how people of different ages feel about a new video game. Instead of waiting for years to see how opinions change, you could just ask people of all ages what they think right now. That's Cross-Sectional Design for you—fast and straightforward.

You'll find this type of research everywhere from marketing studies to healthcare. For instance, you might have heard about surveys asking people what they think about a new product or political issue. Those are usually cross-sectional studies, aimed at getting a quick read on public opinion.

Cross-Sectional Design Pros

So, what's the big deal with Cross-Sectional Design? Well, it's the go-to when you need answers fast and don't have the time or resources for a more complicated setup.

Cross-Sectional Design Cons

Remember, speed comes with trade-offs. While you get your results quickly, those results are stuck in time. They can't tell you how things change or why they're changing, just what's happening right now.

Cross-Sectional Design Uses

Also, because they're so quick and simple, cross-sectional studies often serve as the first step in research. They give scientists an idea of what's going on so they can decide if it's worth digging deeper. In that way, they're a bit like a movie trailer, giving you a taste of the action to see if you're interested in seeing the whole film.

So, in our lineup of experimental designs, if True Experimental Design is the superstar quarterback and Longitudinal Design is the wise elder, then Cross-Sectional Design is like the speedy running back—fast, agile, but not designed for long, drawn-out plays.

7) Correlational Design

Next on our roster is the Correlational Design, the keen observer of the experimental world. Imagine this design as the person at a party who loves people-watching. They don't interfere or get involved; they just observe and take mental notes about what's going on.

In a correlational study, researchers don't change or control anything; they simply observe and measure how two variables relate to each other.

The correlational design has roots in the early days of psychology and sociology. Pioneers like Sir Francis Galton used it to study how qualities like intelligence or height could be related within families.

This design is all about asking, "Hey, when this thing happens, does that other thing usually happen too?" For example, researchers might study whether students who have more study time get better grades or whether people who exercise more have lower stress levels.

One of the most famous correlational studies you might have heard of is the link between smoking and lung cancer. Back in the mid-20th century, researchers started noticing that people who smoked a lot also seemed to get lung cancer more often. They couldn't say smoking caused cancer—that would require a true experiment—but the strong correlation was a red flag that led to more research and eventually, health warnings.

Correlational Design Pros

This design is great at proving that two (or more) things can be related. Correlational designs can help prove that more detailed research is needed on a topic. They can help us see patterns or possible causes for things that we otherwise might not have realized.

Correlational Design Cons

But here's where you need to be careful: correlational designs can be tricky. Just because two things are related doesn't mean one causes the other. That's like saying, "Every time I wear my lucky socks, my team wins." Well, it's a fun thought, but those socks aren't really controlling the game.

Correlational Design Uses

Despite this limitation, correlational designs are popular in psychology, economics, and epidemiology, to name a few fields. They're often the first step in exploring a possible relationship between variables. Once a strong correlation is found, researchers may decide to conduct more rigorous experimental studies to examine cause and effect.

So, if the True Experimental Design is the superstar quarterback and the Longitudinal Design is the wise elder, the Factorial Design is the strategist, and the Cross-Sectional Design is the speedster, then the Correlational Design is the clever scout, identifying interesting patterns but leaving the heavy lifting of proving cause and effect to the other types of designs.

8) Meta-Analysis

Last but not least, let's talk about Meta-Analysis, the librarian of experimental designs.

If other designs are all about creating new research, Meta-Analysis is about gathering up everyone else's research, sorting it, and figuring out what it all means when you put it together.

Imagine a jigsaw puzzle where each piece is a different study. Meta-Analysis is the process of fitting all those pieces together to see the big picture.

The concept of Meta-Analysis started to take shape in the late 20th century, when computers became powerful enough to handle massive amounts of data. It was like someone handed researchers a super-powered magnifying glass, letting them examine multiple studies at the same time to find common trends or results.

You might have heard of the Cochrane Reviews in healthcare . These are big collections of meta-analyses that help doctors and policymakers figure out what treatments work best based on all the research that's been done.

For example, if ten different studies show that a certain medicine helps lower blood pressure, a meta-analysis would pull all that information together to give a more accurate answer.

Meta-Analysis Pros

The beauty of Meta-Analysis is that it can provide really strong evidence. Instead of relying on one study, you're looking at the whole landscape of research on a topic.

Meta-Analysis Cons

However, it does have some downsides. For one, Meta-Analysis is only as good as the studies it includes. If those studies are flawed, the meta-analysis will be too. It's like baking a cake: if you use bad ingredients, it doesn't matter how good your recipe is—the cake won't turn out well.

Meta-Analysis Uses

Despite these challenges, meta-analyses are highly respected and widely used in many fields like medicine, psychology, and education. They help us make sense of a world that's bursting with information by showing us the big picture drawn from many smaller snapshots.

So, in our all-star lineup, if True Experimental Design is the quarterback and Longitudinal Design is the wise elder, the Factorial Design is the strategist, the Cross-Sectional Design is the speedster, and the Correlational Design is the scout, then the Meta-Analysis is like the coach, using insights from everyone else's plays to come up with the best game plan.

9) Non-Experimental Design

Now, let's talk about a player who's a bit of an outsider on this team of experimental designs—the Non-Experimental Design. Think of this design as the commentator or the journalist who covers the game but doesn't actually play.

In a Non-Experimental Design, researchers are like reporters gathering facts, but they don't interfere or change anything. They're simply there to describe and analyze.

Non-Experimental Design Pros

So, what's the deal with Non-Experimental Design? Its strength is in description and exploration. It's really good for studying things as they are in the real world, without changing any conditions.

Non-Experimental Design Cons

Because a non-experimental design doesn't manipulate variables, it can't prove cause and effect. It's like a weather reporter: they can tell you it's raining, but they can't tell you why it's raining.

The downside? Since researchers aren't controlling variables, it's hard to rule out other explanations for what they observe. It's like hearing one side of a story—you get an idea of what happened, but it might not be the complete picture.

Non-Experimental Design Uses

Non-Experimental Design has always been a part of research, especially in fields like anthropology, sociology, and some areas of psychology.

For instance, if you've ever heard of studies that describe how people behave in different cultures or what teens like to do in their free time, that's often Non-Experimental Design at work. These studies aim to capture the essence of a situation, like painting a portrait instead of taking a snapshot.

One well-known example you might have heard about is the Kinsey Reports from the 1940s and 1950s, which described sexual behavior in men and women. Researchers interviewed thousands of people but didn't manipulate any variables like you would in a true experiment. They simply collected data to create a comprehensive picture of the subject matter.

So, in our metaphorical team of research designs, if True Experimental Design is the quarterback and Longitudinal Design is the wise elder, Factorial Design is the strategist, Cross-Sectional Design is the speedster, Correlational Design is the scout, and Meta-Analysis is the coach, then Non-Experimental Design is the sports journalist—always present, capturing the game, but not part of the action itself.

10) Repeated Measures Design

Time to meet the Repeated Measures Design, the time traveler of our research team. If this design were a player in a sports game, it would be the one who keeps revisiting past plays to figure out how to improve the next one.

Repeated Measures Design is all about studying the same people or subjects multiple times to see how they change or react under different conditions.

The idea behind Repeated Measures Design isn't new; it's been around since the early days of psychology and medicine. You could say it's a cousin to the Longitudinal Design, but instead of looking at how things naturally change over time, it focuses on how the same group reacts to different things.

Imagine a study looking at how a new energy drink affects people's running speed. Instead of comparing one group that drank the energy drink to another group that didn't, a Repeated Measures Design would have the same group of people run multiple times—once with the energy drink, and once without. This way, you're really zeroing in on the effect of that energy drink, making the results more reliable.

Repeated Measures Design Pros

The strong point of Repeated Measures Design is that it's super focused. Because it uses the same subjects, you don't have to worry about differences between groups messing up your results.

Repeated Measures Design Cons

But the downside? Well, people can get tired or bored if they're tested too many times, which might affect how they respond.

Repeated Measures Design Uses

A famous example of this design is the "Little Albert" experiment, conducted by John B. Watson and Rosalie Rayner in 1920. In this study, a young boy was exposed to a white rat and other stimuli several times to see how his emotional responses changed. Though the ethical standards of this experiment are often criticized today, it was groundbreaking in understanding conditioned emotional responses.

In our metaphorical lineup of research designs, if True Experimental Design is the quarterback and Longitudinal Design is the wise elder, Factorial Design is the strategist, Cross-Sectional Design is the speedster, Correlational Design is the scout, Meta-Analysis is the coach, and Non-Experimental Design is the journalist, then Repeated Measures Design is the time traveler—always looping back to fine-tune the game plan.

11) Crossover Design

Next up is Crossover Design, the switch-hitter of the research world. If you're familiar with baseball, you'll know a switch-hitter is someone who can bat both right-handed and left-handed.

In a similar way, Crossover Design allows subjects to experience multiple conditions, flipping them around so that everyone gets a turn in each role.

This design is like the utility player on our team—versatile, flexible, and really good at adapting.

The Crossover Design has its roots in medical research and has been popular since the mid-20th century. It's often used in clinical trials to test the effectiveness of different treatments.

Crossover Design Pros

The neat thing about this design is that it allows each participant to serve as their own control group. Imagine you're testing two new kinds of headache medicine. Instead of giving one type to one group and another type to a different group, you'd give both kinds to the same people but at different times.

Crossover Design Cons

What's the big deal with Crossover Design? Its major strength is in reducing the "noise" that comes from individual differences. Since each person experiences all conditions, it's easier to see real effects. However, there's a catch. This design assumes that there's no lasting effect from the first condition when you switch to the second one. That might not always be true. If the first treatment has a long-lasting effect, it could mess up the results when you switch to the second treatment.

Crossover Design Uses

A well-known example of Crossover Design is in studies that look at the effects of different types of diets—like low-carb vs. low-fat diets. Researchers might have participants follow a low-carb diet for a few weeks, then switch them to a low-fat diet. By doing this, they can more accurately measure how each diet affects the same group of people.

In our team of experimental designs, if True Experimental Design is the quarterback and Longitudinal Design is the wise elder, Factorial Design is the strategist, Cross-Sectional Design is the speedster, Correlational Design is the scout, Meta-Analysis is the coach, Non-Experimental Design is the journalist, and Repeated Measures Design is the time traveler, then Crossover Design is the versatile utility player—always ready to adapt and play multiple roles to get the most accurate results.

12) Cluster Randomized Design

Meet the Cluster Randomized Design, the team captain of group-focused research. In our imaginary lineup of experimental designs, if other designs focus on individual players, then Cluster Randomized Design is looking at how the entire team functions.

This approach is especially common in educational and community-based research, and it's been gaining traction since the late 20th century.

Here's how Cluster Randomized Design works: Instead of assigning individual people to different conditions, researchers assign entire groups, or "clusters." These could be schools, neighborhoods, or even entire towns. This helps you see how the new method works in a real-world setting.

Imagine you want to see if a new anti-bullying program really works. Instead of selecting individual students, you'd introduce the program to a whole school or maybe even several schools, and then compare the results to schools without the program.

Cluster Randomized Design Pros

Why use Cluster Randomized Design? Well, sometimes it's just not practical to assign conditions at the individual level. For example, you can't really have half a school following a new reading program while the other half sticks with the old one; that would be way too confusing! Cluster Randomization helps get around this problem by treating each "cluster" as its own mini-experiment.

Cluster Randomized Design Cons

There's a downside, too. Because entire groups are assigned to each condition, there's a risk that the groups might be different in some important way that the researchers didn't account for. That's like having one sports team that's full of veterans playing against a team of rookies; the match wouldn't be fair.

Cluster Randomized Design Uses

A famous example is the research conducted to test the effectiveness of different public health interventions, like vaccination programs. Researchers might roll out a vaccination program in one community but not in another, then compare the rates of disease in both.

In our metaphorical research team, if True Experimental Design is the quarterback, Longitudinal Design is the wise elder, Factorial Design is the strategist, Cross-Sectional Design is the speedster, Correlational Design is the scout, Meta-Analysis is the coach, Non-Experimental Design is the journalist, Repeated Measures Design is the time traveler, and Crossover Design is the utility player, then Cluster Randomized Design is the team captain—always looking out for the group as a whole.

13) Mixed-Methods Design

Say hello to Mixed-Methods Design, the all-rounder or the "Renaissance player" of our research team.

Mixed-Methods Design uses a blend of both qualitative and quantitative methods to get a more complete picture, just like a Renaissance person who's good at lots of different things. It's like being good at both offense and defense in a sport; you've got all your bases covered!

Mixed-Methods Design is a fairly new kid on the block, becoming more popular in the late 20th and early 21st centuries as researchers began to see the value in using multiple approaches to tackle complex questions. It's the Swiss Army knife in our research toolkit, combining the best parts of other designs to be more versatile.

Here's how it could work: Imagine you're studying the effects of a new educational app on students' math skills. You might use quantitative methods like tests and grades to measure how much the students improve—that's the 'numbers part.'

But you also want to know how the students feel about math now, or why they think they got better or worse. For that, you could conduct interviews or have students fill out journals—that's the 'story part.'

Mixed-Methods Design Pros

So, what's the scoop on Mixed-Methods Design? The strength is its versatility and depth; you're not just getting numbers or stories, you're getting both, which gives a fuller picture.

Mixed-Methods Design Cons

But, it's also more challenging. Imagine trying to play two sports at the same time! You have to be skilled in different research methods and know how to combine them effectively.

Mixed-Methods Design Uses

A high-profile example of Mixed-Methods Design is research on climate change. Scientists use numbers and data to show temperature changes (quantitative), but they also interview people to understand how these changes are affecting communities (qualitative).

In our team of experimental designs, if True Experimental Design is the quarterback, Longitudinal Design is the wise elder, Factorial Design is the strategist, Cross-Sectional Design is the speedster, Correlational Design is the scout, Meta-Analysis is the coach, Non-Experimental Design is the journalist, Repeated Measures Design is the time traveler, Crossover Design is the utility player, and Cluster Randomized Design is the team captain, then Mixed-Methods Design is the Renaissance player—skilled in multiple areas and able to bring them all together for a winning strategy.

14) Multivariate Design

Now, let's turn our attention to Multivariate Design, the multitasker of the research world.

If our lineup of research designs were like players on a basketball court, Multivariate Design would be the player dribbling, passing, and shooting all at once. This design doesn't just look at one or two things; it looks at several variables simultaneously to see how they interact and affect each other.

Multivariate Design is like baking a cake with many ingredients. Instead of just looking at how flour affects the cake, you also consider sugar, eggs, and milk all at once. This way, you understand how everything works together to make the cake taste good or bad.

Multivariate Design has been a go-to method in psychology, economics, and social sciences since the latter half of the 20th century. With the advent of computers and advanced statistical software, analyzing multiple variables at once became a lot easier, and Multivariate Design soared in popularity.

Multivariate Design Pros

So, what's the benefit of using Multivariate Design? Its power lies in its complexity. By studying multiple variables at the same time, you can get a really rich, detailed understanding of what's going on.

Multivariate Design Cons

But that complexity can also be a drawback. With so many variables, it can be tough to tell which ones are really making a difference and which ones are just along for the ride.

Multivariate Design Uses

Imagine you're a coach trying to figure out the best strategy to win games. You wouldn't just look at how many points your star player scores; you'd also consider assists, rebounds, turnovers, and maybe even how loud the crowd is. A Multivariate Design would help you understand how all these factors work together to determine whether you win or lose.

A well-known example of Multivariate Design is in market research. Companies often use this approach to figure out how different factors—like price, packaging, and advertising—affect sales. By studying multiple variables at once, they can find the best combination to boost profits.

In our metaphorical research team, if True Experimental Design is the quarterback, Longitudinal Design is the wise elder, Factorial Design is the strategist, Cross-Sectional Design is the speedster, Correlational Design is the scout, Meta-Analysis is the coach, Non-Experimental Design is the journalist, Repeated Measures Design is the time traveler, Crossover Design is the utility player, Cluster Randomized Design is the team captain, and Mixed-Methods Design is the Renaissance player, then Multivariate Design is the multitasker—juggling many variables at once to get a fuller picture of what's happening.

15) Pretest-Posttest Design

Let's introduce Pretest-Posttest Design, the "Before and After" superstar of our research team. You've probably seen those before-and-after pictures in ads for weight loss programs or home renovations, right?

Well, this design is like that, but for science! Pretest-Posttest Design checks out what things are like before the experiment starts and then compares that to what things are like after the experiment ends.

This design is one of the classics, a staple in research for decades across various fields like psychology, education, and healthcare. It's so simple and straightforward that it has stayed popular for a long time.

In Pretest-Posttest Design, you measure your subject's behavior or condition before you introduce any changes—that's your "before" or "pretest." Then you do your experiment, and after it's done, you measure the same thing again—that's your "after" or "posttest."

Pretest-Posttest Design Pros

What makes Pretest-Posttest Design special? It's pretty easy to understand and doesn't require fancy statistics.

Pretest-Posttest Design Cons

But there are some pitfalls. For example, what if the kids in our math example get better at multiplication just because they're older or because they've taken the test before? That would make it hard to tell if the program is really effective or not.

Pretest-Posttest Design Uses

Let's say you're a teacher and you want to know if a new math program helps kids get better at multiplication. First, you'd give all the kids a multiplication test—that's your pretest. Then you'd teach them using the new math program. At the end, you'd give them the same test again—that's your posttest. If the kids do better on the second test, you might conclude that the program works.

One famous use of Pretest-Posttest Design is in evaluating the effectiveness of driver's education courses. Researchers will measure people's driving skills before and after the course to see if they've improved.

16) Solomon Four-Group Design

Next up is the Solomon Four-Group Design, the "chess master" of our research team. This design is all about strategy and careful planning. Named after Richard L. Solomon who introduced it in the 1940s, this method tries to correct some of the weaknesses in simpler designs, like the Pretest-Posttest Design.

Here's how it rolls: The Solomon Four-Group Design uses four different groups to test a hypothesis. Two groups get a pretest, then one of them receives the treatment or intervention, and both get a posttest. The other two groups skip the pretest, and only one of them receives the treatment before they both get a posttest.

Sound complicated? It's like playing 4D chess; you're thinking several moves ahead!

Solomon Four-Group Design Pros

What's the pro and con of the Solomon Four-Group Design? On the plus side, it provides really robust results because it accounts for so many variables.

Solomon Four-Group Design Cons

The downside? It's a lot of work and requires a lot of participants, making it more time-consuming and costly.

Solomon Four-Group Design Uses

Let's say you want to figure out if a new way of teaching history helps students remember facts better. Two classes take a history quiz (pretest), then one class uses the new teaching method while the other sticks with the old way. Both classes take another quiz afterward (posttest).

Meanwhile, two more classes skip the initial quiz, and then one uses the new method before both take the final quiz. Comparing all four groups will give you a much clearer picture of whether the new teaching method works and whether the pretest itself affects the outcome.

The Solomon Four-Group Design is less commonly used than simpler designs but is highly respected for its ability to control for more variables. It's a favorite in educational and psychological research where you really want to dig deep and figure out what's actually causing changes.

17) Adaptive Designs

Now, let's talk about Adaptive Designs, the chameleons of the experimental world.

Imagine you're a detective, and halfway through solving a case, you find a clue that changes everything. You wouldn't just stick to your old plan; you'd adapt and change your approach, right? That's exactly what Adaptive Designs allow researchers to do.

In an Adaptive Design, researchers can make changes to the study as it's happening, based on early results. In a traditional study, once you set your plan, you stick to it from start to finish.

Adaptive Design Pros

This method is particularly useful in fast-paced or high-stakes situations, like developing a new vaccine in the middle of a pandemic. The ability to adapt can save both time and resources, and more importantly, it can save lives by getting effective treatments out faster.

Adaptive Design Cons

But Adaptive Designs aren't without their drawbacks. They can be very complex to plan and carry out, and there's always a risk that the changes made during the study could introduce bias or errors.

Adaptive Design Uses

Adaptive Designs are most often seen in clinical trials, particularly in the medical and pharmaceutical fields.

For instance, if a new drug is showing really promising results, the study might be adjusted to give more participants the new treatment instead of a placebo. Or if one dose level is showing bad side effects, it might be dropped from the study.

The best part is, these changes are pre-planned. Researchers lay out in advance what changes might be made and under what conditions, which helps keep everything scientific and above board.

In terms of applications, besides their heavy usage in medical and pharmaceutical research, Adaptive Designs are also becoming increasingly popular in software testing and market research. In these fields, being able to quickly adjust to early results can give companies a significant advantage.

Adaptive Designs are like the agile startups of the research world—quick to pivot, keen to learn from ongoing results, and focused on rapid, efficient progress. However, they require a great deal of expertise and careful planning to ensure that the adaptability doesn't compromise the integrity of the research.

18) Bayesian Designs

Next, let's dive into Bayesian Designs, the data detectives of the research universe. Named after Thomas Bayes, an 18th-century statistician and minister, this design doesn't just look at what's happening now; it also takes into account what's happened before.

Imagine if you were a detective who not only looked at the evidence in front of you but also used your past cases to make better guesses about your current one. That's the essence of Bayesian Designs.

Bayesian Designs are like detective work in science. As you gather more clues (or data), you update your best guess on what's really happening. This way, your experiment gets smarter as it goes along.

In the world of research, Bayesian Designs are most notably used in areas where you have some prior knowledge that can inform your current study. For example, if earlier research shows that a certain type of medicine usually works well for a specific illness, a Bayesian Design would include that information when studying a new group of patients with the same illness.

Bayesian Design Pros

One of the major advantages of Bayesian Designs is their efficiency. Because they use existing data to inform the current experiment, often fewer resources are needed to reach a reliable conclusion.

Bayesian Design Cons

However, they can be quite complicated to set up and require a deep understanding of both statistics and the subject matter at hand.

Bayesian Design Uses

Bayesian Designs are highly valued in medical research, finance, environmental science, and even in Internet search algorithms. Their ability to continually update and refine hypotheses based on new evidence makes them particularly useful in fields where data is constantly evolving and where quick, informed decisions are crucial.

Here's a real-world example: In the development of personalized medicine, where treatments are tailored to individual patients, Bayesian Designs are invaluable. If a treatment has been effective for patients with similar genetics or symptoms in the past, a Bayesian approach can use that data to predict how well it might work for a new patient.

This type of design is also increasingly popular in machine learning and artificial intelligence. In these fields, Bayesian Designs help algorithms "learn" from past data to make better predictions or decisions in new situations. It's like teaching a computer to be a detective that gets better and better at solving puzzles the more puzzles it sees.

19) Covariate Adaptive Randomization

Now let's turn our attention to Covariate Adaptive Randomization, which you can think of as the "matchmaker" of experimental designs.

Picture a soccer coach trying to create the most balanced teams for a friendly match. They wouldn't just randomly assign players; they'd take into account each player's skills, experience, and other traits.

Covariate Adaptive Randomization is all about creating the most evenly matched groups possible for an experiment.

In traditional randomization, participants are allocated to different groups purely by chance. This is a pretty fair way to do things, but it can sometimes lead to unbalanced groups.

Imagine if all the professional-level players ended up on one soccer team and all the beginners on another; that wouldn't be a very informative match! Covariate Adaptive Randomization fixes this by using important traits or characteristics (called "covariates") to guide the randomization process.

Covariate Adaptive Randomization Pros

The benefits of this design are pretty clear: it aims for balance and fairness, making the final results more trustworthy.

Covariate Adaptive Randomization Cons

But it's not perfect. It can be complex to implement and requires a deep understanding of which characteristics are most important to balance.

Covariate Adaptive Randomization Uses

This design is particularly useful in medical trials. Let's say researchers are testing a new medication for high blood pressure. Participants might have different ages, weights, or pre-existing conditions that could affect the results.

Covariate Adaptive Randomization would make sure that each treatment group has a similar mix of these characteristics, making the results more reliable and easier to interpret.

In practical terms, this design is often seen in clinical trials for new drugs or therapies, but its principles are also applicable in fields like psychology, education, and social sciences.

For instance, in educational research, it might be used to ensure that classrooms being compared have similar distributions of students in terms of academic ability, socioeconomic status, and other factors.

Covariate Adaptive Randomization is like the wise elder of the group, ensuring that everyone has an equal opportunity to show their true capabilities, thereby making the collective results as reliable as possible.

20) Stepped Wedge Design

Let's now focus on the Stepped Wedge Design, a thoughtful and cautious member of the experimental design family.

Imagine you're trying out a new gardening technique, but you're not sure how well it will work. You decide to apply it to one section of your garden first, watch how it performs, and then gradually extend the technique to other sections. This way, you get to see its effects over time and across different conditions. That's basically how Stepped Wedge Design works.

In a Stepped Wedge Design, all participants or clusters start off in the control group, and then, at different times, they 'step' over to the intervention or treatment group. This creates a wedge-like pattern over time where more and more participants receive the treatment as the study progresses. It's like rolling out a new policy in phases, monitoring its impact at each stage before extending it to more people.

Stepped Wedge Design Pros

The Stepped Wedge Design offers several advantages. Firstly, it allows for the study of interventions that are expected to do more good than harm, which makes it ethically appealing.

Secondly, it's useful when resources are limited and it's not feasible to roll out a new treatment to everyone at once. Lastly, because everyone eventually receives the treatment, it can be easier to get buy-in from participants or organizations involved in the study.

Stepped Wedge Design Cons

However, this design can be complex to analyze because it has to account for both the time factor and the changing conditions in each 'step' of the wedge. And like any study where participants know they're receiving an intervention, there's the potential for the results to be influenced by the placebo effect or other biases.

Stepped Wedge Design Uses

This design is particularly useful in health and social care research. For instance, if a hospital wants to implement a new hygiene protocol, it might start in one department, assess its impact, and then roll it out to other departments over time. This allows the hospital to adjust and refine the new protocol based on real-world data before it's fully implemented.

In terms of applications, Stepped Wedge Designs are commonly used in public health initiatives, organizational changes in healthcare settings, and social policy trials. They are particularly useful in situations where an intervention is being rolled out gradually and it's important to understand its impacts at each stage.

21) Sequential Design

Next up is Sequential Design, the dynamic and flexible member of our experimental design family.

Imagine you're playing a video game where you can choose different paths. If you take one path and find a treasure chest, you might decide to continue in that direction. If you hit a dead end, you might backtrack and try a different route. Sequential Design operates in a similar fashion, allowing researchers to make decisions at different stages based on what they've learned so far.

In a Sequential Design, the experiment is broken down into smaller parts, or "sequences." After each sequence, researchers pause to look at the data they've collected. Based on those findings, they then decide whether to stop the experiment because they've got enough information, or to continue and perhaps even modify the next sequence.

Sequential Design Pros

This allows for a more efficient use of resources, as you're only continuing with the experiment if the data suggests it's worth doing so.

One of the great things about Sequential Design is its efficiency. Because you're making data-driven decisions along the way, you can often reach conclusions more quickly and with fewer resources.

Sequential Design Cons

However, it requires careful planning and expertise to ensure that these "stop or go" decisions are made correctly and without bias.

Sequential Design Uses

In terms of its applications, besides healthcare and medicine, Sequential Design is also popular in quality control in manufacturing, environmental monitoring, and financial modeling. In these areas, being able to make quick decisions based on incoming data can be a big advantage.

This design is often used in clinical trials involving new medications or treatments. For example, if early results show that a new drug has significant side effects, the trial can be stopped before more people are exposed to it.

On the flip side, if the drug is showing promising results, the trial might be expanded to include more participants or to extend the testing period.

Think of Sequential Design as the nimble athlete of experimental designs, capable of quick pivots and adjustments to reach the finish line in the most effective way possible. But just like an athlete needs a good coach, this design requires expert oversight to make sure it stays on the right track.

22) Field Experiments

Last but certainly not least, let's explore Field Experiments—the adventurers of the experimental design world.

Picture a scientist leaving the controlled environment of a lab to test a theory in the real world, like a biologist studying animals in their natural habitat or a social scientist observing people in a real community. These are Field Experiments, and they're all about getting out there and gathering data in real-world settings.

Field Experiments embrace the messiness of the real world, unlike laboratory experiments, where everything is controlled down to the smallest detail. This makes them both exciting and challenging.

Field Experiment Pros

On one hand, the results often give us a better understanding of how things work outside the lab.

While Field Experiments offer real-world relevance, they come with challenges like controlling for outside factors and the ethical considerations of intervening in people's lives without their knowledge.

Field Experiment Cons

On the other hand, the lack of control can make it harder to tell exactly what's causing what. Yet, despite these challenges, they remain a valuable tool for researchers who want to understand how theories play out in the real world.

Field Experiment Uses

Let's say a school wants to improve student performance. In a Field Experiment, they might change the school's daily schedule for one semester and keep track of how students perform compared to another school where the schedule remained the same.

Because the study is happening in a real school with real students, the results could be very useful for understanding how the change might work in other schools. But since it's the real world, lots of other factors—like changes in teachers or even the weather—could affect the results.

Field Experiments are widely used in economics, psychology, education, and public policy. For example, you might have heard of the famous "Broken Windows" experiment in the 1980s that looked at how small signs of disorder, like broken windows or graffiti, could encourage more serious crime in neighborhoods. This experiment had a big impact on how cities think about crime prevention.

From the foundational concepts of control groups and independent variables to the sophisticated layouts like Covariate Adaptive Randomization and Sequential Design, it's clear that the realm of experimental design is as varied as it is fascinating.

We've seen that each design has its own special talents, ideal for specific situations. Some designs, like the Classic Controlled Experiment, are like reliable old friends you can always count on.

Others, like Sequential Design, are flexible and adaptable, making quick changes based on what they learn. And let's not forget the adventurous Field Experiments, which take us out of the lab and into the real world to discover things we might not see otherwise.

Choosing the right experimental design is like picking the right tool for the job. The method you choose can make a big difference in how reliable your results are and how much people will trust what you've discovered. And as we've learned, there's a design to suit just about every question, every problem, and every curiosity.

So the next time you read about a new discovery in medicine, psychology, or any other field, you'll have a better understanding of the thought and planning that went into figuring things out. Experimental design is more than just a set of rules; it's a structured way to explore the unknown and answer questions that can change the world.

Related posts:

• Experimental Psychologist Career (Salary + Duties + Interviews)
• 40+ Famous Psychologists (Images + Biographies)
• 11+ Psychology Experiment Ideas (Goals + Methods)
• The Little Albert Experiment
• 41+ White Collar Job Examples (Salary + Path)

Reference this article:

About The Author

Free Personality Test

Free Memory Test

Free IQ Test

PracticalPie.com is a participant in the Amazon Associates Program. As an Amazon Associate we earn from qualifying purchases.

Follow Us On:

Youtube Facebook Instagram X/Twitter

Psychology Resources

Developmental

Personality

Relationships

Psychologists

Serial Killers

Psychology Tests

Personality Quiz

Memory Test

Depression test

Type A/B Personality Test

© PracticalPsychology. All rights reserved

Privacy Policy | Terms of Use

Have a language expert improve your writing

Run a free plagiarism check in 10 minutes, generate accurate citations for free.

• Knowledge Base

Methodology

• Control Groups and Treatment Groups | Uses & Examples

Control Groups and Treatment Groups | Uses & Examples

Published on July 3, 2020 by Lauren Thomas . Revised on June 22, 2023.

In a scientific study, a control group is used to establish causality by isolating the effect of an independent variable .

Here, researchers change the independent variable in the treatment group and keep it constant in the control group. Then they compare the results of these groups.

Using a control group means that any change in the dependent variable can be attributed to the independent variable. This helps avoid extraneous variables or confounding variables from impacting your work, as well as a few types of research bias , like omitted variable bias .

Table of contents

Control groups in experiments, control groups in non-experimental research, importance of control groups, other interesting articles, frequently asked questions about control groups.

Control groups are essential to experimental design . When researchers are interested in the impact of a new treatment, they randomly divide their study participants into at least two groups:

• The treatment group (also called the experimental group ) receives the treatment whose effect the researcher is interested in.
• The control group receives either no treatment, a standard treatment whose effect is already known, or a placebo (a fake treatment to control for placebo effect ).

The treatment is any independent variable manipulated by the experimenters, and its exact form depends on the type of research being performed. In a medical trial, it might be a new drug or therapy. In public policy studies, it could be a new social policy that some receive and not others.

In a well-designed experiment, all variables apart from the treatment should be kept constant between the two groups. This means researchers can correctly measure the entire effect of the treatment without interference from confounding variables .

• You pay the students in the treatment group for achieving high grades.
• Students in the control group do not receive any money.

Studies can also include more than one treatment or control group. Researchers might want to examine the impact of multiple treatments at once, or compare a new treatment to several alternatives currently available.

• The treatment group gets the new pill.
• Control group 1 gets an identical-looking sugar pill (a placebo)
• Control group 2 gets a pill already approved to treat high blood pressure

Since the only variable that differs between the three groups is the type of pill, any differences in average blood pressure between the three groups can be credited to the type of pill they received.

• The difference between the treatment group and control group 1 demonstrates the effectiveness of the pill as compared to no treatment.
• The difference between the treatment group and control group 2 shows whether the new pill improves on treatments already available on the market.

Here's why students love Scribbr's proofreading services

Discover proofreading & editing

Although control groups are more common in experimental research, they can be used in other types of research too. Researchers generally rely on non-experimental control groups in two cases: quasi-experimental or matching design.

Control groups in quasi-experimental design

While true experiments rely on random assignment to the treatment or control groups, quasi-experimental design uses some criterion other than randomization to assign people.

Often, these assignments are not controlled by researchers, but are pre-existing groups that have received different treatments. For example, researchers could study the effects of a new teaching method that was applied in some classes in a school but not others, or study the impact of a new policy that is implemented in one state but not in the neighboring state.

In these cases, the classes that did not use the new teaching method, or the state that did not implement the new policy, is the control group.

Control groups in matching design

In correlational research , matching represents a potential alternate option when you cannot use either true or quasi-experimental designs.

In matching designs, the researcher matches individuals who received the “treatment”, or independent variable under study, to others who did not–the control group.

Each member of the treatment group thus has a counterpart in the control group identical in every way possible outside of the treatment. This ensures that the treatment is the only source of potential differences in outcomes between the two groups.

Control groups help ensure the internal validity of your research. You might see a difference over time in your dependent variable in your treatment group. However, without a control group, it is difficult to know whether the change has arisen from the treatment. It is possible that the change is due to some other variables.

If you use a control group that is identical in every other way to the treatment group, you know that the treatment–the only difference between the two groups–must be what has caused the change.

For example, people often recover from illnesses or injuries over time regardless of whether they’ve received effective treatment or not. Thus, without a control group, it’s difficult to determine whether improvements in medical conditions come from a treatment or just the natural progression of time.

Risks from invalid control groups

If your control group differs from the treatment group in ways that you haven’t accounted for, your results may reflect the interference of confounding variables instead of your independent variable.

Minimizing this risk

A few methods can aid you in minimizing the risk from invalid control groups.

• Ensure that all potential confounding variables are accounted for , preferably through an experimental design if possible, since it is difficult to control for all the possible confounders outside of an experimental environment.
• Use double-blinding . This will prevent the members of each group from modifying their behavior based on whether they were placed in the treatment or control group, which could then lead to biased outcomes.
• Randomly assign your subjects into control and treatment groups. This method will allow you to not only minimize the differences between the two groups on confounding variables that you can directly observe, but also those you cannot.

If you want to know more about statistics , methodology , or research bias , make sure to check out some of our other articles with explanations and examples.

• Student’s  t -distribution
• Normal distribution
• Null and Alternative Hypotheses
• Chi square tests
• Confidence interval
• Quartiles & Quantiles
• Cluster sampling
• Stratified sampling
• Data cleansing
• Reproducibility vs Replicability
• Peer review
• Prospective cohort study

Research bias

• Implicit bias
• Cognitive bias
• Placebo effect
• Hawthorne effect
• Hindsight bias
• Affect heuristic
• Social desirability bias

Prevent plagiarism. Run a free check.

An experimental group, also known as a treatment group, receives the treatment whose effect researchers wish to study, whereas a control group does not. They should be identical in all other ways.

A true experiment (a.k.a. a controlled experiment) always includes at least one control group that doesn’t receive the experimental treatment.

However, some experiments use a within-subjects design to test treatments without a control group. In these designs, you usually compare one group’s outcomes before and after a treatment (instead of comparing outcomes between different groups).

For strong internal validity , it’s usually best to include a control group if possible. Without a control group, it’s harder to be certain that the outcome was caused by the experimental treatment and not by other variables.

A confounding variable , also called a confounder or confounding factor, is a third variable in a study examining a potential cause-and-effect relationship.

A confounding variable is related to both the supposed cause and the supposed effect of the study. It can be difficult to separate the true effect of the independent variable from the effect of the confounding variable.

In your research design , it’s important to identify potential confounding variables and plan how you will reduce their impact.

There are several methods you can use to decrease the impact of confounding variables on your research: restriction, matching, statistical control and randomization.

In restriction , you restrict your sample by only including certain subjects that have the same values of potential confounding variables.

In matching , you match each of the subjects in your treatment group with a counterpart in the comparison group. The matched subjects have the same values on any potential confounding variables, and only differ in the independent variable .

In statistical control , you include potential confounders as variables in your regression .

In randomization , you randomly assign the treatment (or independent variable) in your study to a sufficiently large number of subjects, which allows you to control for all potential confounding variables.

Experimental design means planning a set of procedures to investigate a relationship between variables . To design a controlled experiment, you need:

• A testable hypothesis
• At least one independent variable that can be precisely manipulated
• At least one dependent variable that can be precisely measured

When designing the experiment, you decide:

• How you will manipulate the variable(s)
• How you will control for any potential confounding variables
• How many subjects or samples will be included in the study
• How subjects will be assigned to treatment levels

Experimental design is essential to the internal and external validity of your experiment.

Cite this Scribbr article

If you want to cite this source, you can copy and paste the citation or click the “Cite this Scribbr article” button to automatically add the citation to our free Citation Generator.

Thomas, L. (2023, June 22). Control Groups and Treatment Groups | Uses & Examples. Scribbr. Retrieved September 9, 2024, from https://www.scribbr.com/methodology/control-group/

Is this article helpful?

Lauren Thomas

Other students also liked, what is a controlled experiment | definitions & examples, random assignment in experiments | introduction & examples, single, double, & triple blind study | definition & examples, "i thought ai proofreading was useless but..".

I've been using Scribbr for years now and I know it's a service that won't disappoint. It does a good job spotting mistakes”

Want to create or adapt books like this? Learn more about how Pressbooks supports open publishing practices.

Chapter 6: Experimental Research

Experimental Design

Learning Objectives

• Explain the difference between between-subjects and within-subjects experiments, list some of the pros and cons of each approach, and decide which approach to use to answer a particular research question.
• Define random assignment, distinguish it from random sampling, explain its purpose in experimental research, and use some simple strategies to implement it.
• Define what a control condition is, explain its purpose in research on treatment effectiveness, and describe some alternative types of control conditions.
• Define several types of carryover effect, give examples of each, and explain how counterbalancing helps to deal with them.

In this section, we look at some different ways to design an experiment. The primary distinction we will make is between approaches in which each participant experiences one level of the independent variable and approaches in which each participant experiences all levels of the independent variable. The former are called between-subjects experiments and the latter are called within-subjects experiments.

Between-Subjects Experiments

In a  between-subjects experiment , each participant is tested in only one condition. For example, a researcher with a sample of 100 university  students might assign half of them to write about a traumatic event and the other half write about a neutral event. Or a researcher with a sample of 60 people with severe agoraphobia (fear of open spaces) might assign 20 of them to receive each of three different treatments for that disorder. It is essential in a between-subjects experiment that the researcher assign participants to conditions so that the different groups are, on average, highly similar to each other. Those in a trauma condition and a neutral condition, for example, should include a similar proportion of men and women, and they should have similar average intelligence quotients (IQs), similar average levels of motivation, similar average numbers of health problems, and so on. This matching is a matter of controlling these extraneous participant variables across conditions so that they do not become confounding variables.

Random Assignment

The primary way that researchers accomplish this kind of control of extraneous variables across conditions is called  random assignment , which means using a random process to decide which participants are tested in which conditions. Do not confuse random assignment with random sampling. Random sampling is a method for selecting a sample from a population, and it is rarely used in psychological research. Random assignment is a method for assigning participants in a sample to the different conditions, and it is an important element of all experimental research in psychology and other fields too.

In its strictest sense, random assignment should meet two criteria. One is that each participant has an equal chance of being assigned to each condition (e.g., a 50% chance of being assigned to each of two conditions). The second is that each participant is assigned to a condition independently of other participants. Thus one way to assign participants to two conditions would be to flip a coin for each one. If the coin lands heads, the participant is assigned to Condition A, and if it lands tails, the participant is assigned to Condition B. For three conditions, one could use a computer to generate a random integer from 1 to 3 for each participant. If the integer is 1, the participant is assigned to Condition A; if it is 2, the participant is assigned to Condition B; and if it is 3, the participant is assigned to Condition C. In practice, a full sequence of conditions—one for each participant expected to be in the experiment—is usually created ahead of time, and each new participant is assigned to the next condition in the sequence as he or she is tested. When the procedure is computerized, the computer program often handles the random assignment.

One problem with coin flipping and other strict procedures for random assignment is that they are likely to result in unequal sample sizes in the different conditions. Unequal sample sizes are generally not a serious problem, and you should never throw away data you have already collected to achieve equal sample sizes. However, for a fixed number of participants, it is statistically most efficient to divide them into equal-sized groups. It is standard practice, therefore, to use a kind of modified random assignment that keeps the number of participants in each group as similar as possible. One approach is block randomization . In block randomization, all the conditions occur once in the sequence before any of them is repeated. Then they all occur again before any of them is repeated again. Within each of these “blocks,” the conditions occur in a random order. Again, the sequence of conditions is usually generated before any participants are tested, and each new participant is assigned to the next condition in the sequence.  Table 6.2  shows such a sequence for assigning nine participants to three conditions. The Research Randomizer website will generate block randomization sequences for any number of participants and conditions. Again, when the procedure is computerized, the computer program often handles the block randomization.

Random assignment is not guaranteed to control all extraneous variables across conditions. It is always possible that just by chance, the participants in one condition might turn out to be substantially older, less tired, more motivated, or less depressed on average than the participants in another condition. However, there are some reasons that this possibility is not a major concern. One is that random assignment works better than one might expect, especially for large samples. Another is that the inferential statistics that researchers use to decide whether a difference between groups reflects a difference in the population takes the “fallibility” of random assignment into account. Yet another reason is that even if random assignment does result in a confounding variable and therefore produces misleading results, this confound is likely to be detected when the experiment is replicated. The upshot is that random assignment to conditions—although not infallible in terms of controlling extraneous variables—is always considered a strength of a research design.

Treatment and Control Conditions

Between-subjects experiments are often used to determine whether a treatment works. In psychological research, a  treatment  is any intervention meant to change people’s behaviour for the better. This  intervention  includes psychotherapies and medical treatments for psychological disorders but also interventions designed to improve learning, promote conservation, reduce prejudice, and so on. To determine whether a treatment works, participants are randomly assigned to either a  treatment condition , in which they receive the treatment, or a control condition , in which they do not receive the treatment. If participants in the treatment condition end up better off than participants in the control condition—for example, they are less depressed, learn faster, conserve more, express less prejudice—then the researcher can conclude that the treatment works. In research on the effectiveness of psychotherapies and medical treatments, this type of experiment is often called a randomized clinical trial .

There are different types of control conditions. In a  no-treatment control condition , participants receive no treatment whatsoever. One problem with this approach, however, is the existence of placebo effects. A  placebo  is a simulated treatment that lacks any active ingredient or element that should make it effective, and a  placebo effect  is a positive effect of such a treatment. Many folk remedies that seem to work—such as eating chicken soup for a cold or placing soap under the bedsheets to stop nighttime leg cramps—are probably nothing more than placebos. Although placebo effects are not well understood, they are probably driven primarily by people’s expectations that they will improve. Having the expectation to improve can result in reduced stress, anxiety, and depression, which can alter perceptions and even improve immune system functioning (Price, Finniss, & Benedetti, 2008) [1] .

Placebo effects are interesting in their own right (see  Note “The Powerful Placebo” ), but they also pose a serious problem for researchers who want to determine whether a treatment works.  Figure 6.2  shows some hypothetical results in which participants in a treatment condition improved more on average than participants in a no-treatment control condition. If these conditions (the two leftmost bars in  Figure 6.2 ) were the only conditions in this experiment, however, one could not conclude that the treatment worked. It could be instead that participants in the treatment group improved more because they expected to improve, while those in the no-treatment control condition did not.

Fortunately, there are several solutions to this problem. One is to include a placebo control condition , in which participants receive a placebo that looks much like the treatment but lacks the active ingredient or element thought to be responsible for the treatment’s effectiveness. When participants in a treatment condition take a pill, for example, then those in a placebo control condition would take an identical-looking pill that lacks the active ingredient in the treatment (a “sugar pill”). In research on psychotherapy effectiveness, the placebo might involve going to a psychotherapist and talking in an unstructured way about one’s problems. The idea is that if participants in both the treatment and the placebo control groups expect to improve, then any improvement in the treatment group over and above that in the placebo control group must have been caused by the treatment and not by participants’ expectations. This  difference  is what is shown by a comparison of the two outer bars in  Figure 6.2 .

Of course, the principle of informed consent requires that participants be told that they will be assigned to either a treatment or a placebo control condition—even though they cannot be told which until the experiment ends. In many cases the participants who had been in the control condition are then offered an opportunity to have the real treatment. An alternative approach is to use a waitlist control condition , in which participants are told that they will receive the treatment but must wait until the participants in the treatment condition have already received it. This disclosure allows researchers to compare participants who have received the treatment with participants who are not currently receiving it but who still expect to improve (eventually). A final solution to the problem of placebo effects is to leave out the control condition completely and compare any new treatment with the best available alternative treatment. For example, a new treatment for simple phobia could be compared with standard exposure therapy. Because participants in both conditions receive a treatment, their expectations about improvement should be similar. This approach also makes sense because once there is an effective treatment, the interesting question about a new treatment is not simply “Does it work?” but “Does it work better than what is already available?

The Powerful Placebo

Many people are not surprised that placebos can have a positive effect on disorders that seem fundamentally psychological, including depression, anxiety, and insomnia. However, placebos can also have a positive effect on disorders that most people think of as fundamentally physiological. These include asthma, ulcers, and warts (Shapiro & Shapiro, 1999) [2] . There is even evidence that placebo surgery—also called “sham surgery”—can be as effective as actual surgery.

Medical researcher J. Bruce Moseley and his colleagues conducted a study on the effectiveness of two arthroscopic surgery procedures for osteoarthritis of the knee (Moseley et al., 2002) [3] . The control participants in this study were prepped for surgery, received a tranquilizer, and even received three small incisions in their knees. But they did not receive the actual arthroscopic surgical procedure. The surprising result was that all participants improved in terms of both knee pain and function, and the sham surgery group improved just as much as the treatment groups. According to the researchers, “This study provides strong evidence that arthroscopic lavage with or without débridement [the surgical procedures used] is not better than and appears to be equivalent to a placebo procedure in improving knee pain and self-reported function” (p. 85).

Within-Subjects Experiments

In a within-subjects experiment , each participant is tested under all conditions. Consider an experiment on the effect of a defendant’s physical attractiveness on judgments of his guilt. Again, in a between-subjects experiment, one group of participants would be shown an attractive defendant and asked to judge his guilt, and another group of participants would be shown an unattractive defendant and asked to judge his guilt. In a within-subjects experiment, however, the same group of participants would judge the guilt of both an attractive and an unattractive defendant.

The primary advantage of this approach is that it provides maximum control of extraneous participant variables. Participants in all conditions have the same mean IQ, same socioeconomic status, same number of siblings, and so on—because they are the very same people. Within-subjects experiments also make it possible to use statistical procedures that remove the effect of these extraneous participant variables on the dependent variable and therefore make the data less “noisy” and the effect of the independent variable easier to detect. We will look more closely at this idea later in the book.  However, not all experiments can use a within-subjects design nor would it be desirable to.

Carryover Effects and Counterbalancing

The primary disad vantage of within-subjects designs is that they can result in carryover effects. A  carryover effect  is an effect of being tested in one condition on participants’ behaviour in later conditions. One type of carryover effect is a  practice effect , where participants perform a task better in later conditions because they have had a chance to practice it. Another type is a fatigue effect , where participants perform a task worse in later conditions because they become tired or bored. Being tested in one condition can also change how participants perceive stimuli or interpret their task in later conditions. This  type of effect  is called a  context effect . For example, an average-looking defendant might be judged more harshly when participants have just judged an attractive defendant than when they have just judged an unattractive defendant. Within-subjects experiments also make it easier for participants to guess the hypothesis. For example, a participant who is asked to judge the guilt of an attractive defendant and then is asked to judge the guilt of an unattractive defendant is likely to guess that the hypothesis is that defendant attractiveness affects judgments of guilt. This  knowledge  could lead the participant to judge the unattractive defendant more harshly because he thinks this is what he is expected to do. Or it could make participants judge the two defendants similarly in an effort to be “fair.”

Carryover effects can be interesting in their own right. (Does the attractiveness of one person depend on the attractiveness of other people that we have seen recently?) But when they are not the focus of the research, carryover effects can be problematic. Imagine, for example, that participants judge the guilt of an attractive defendant and then judge the guilt of an unattractive defendant. If they judge the unattractive defendant more harshly, this might be because of his unattractiveness. But it could be instead that they judge him more harshly because they are becoming bored or tired. In other words, the order of the conditions is a confounding variable. The attractive condition is always the first condition and the unattractive condition the second. Thus any difference between the conditions in terms of the dependent variable could be caused by the order of the conditions and not the independent variable itself.

There is a solution to the problem of order effects, however, that can be used in many situations. It is  counterbalancing , which means testing different participants in different orders. For example, some participants would be tested in the attractive defendant condition followed by the unattractive defendant condition, and others would be tested in the unattractive condition followed by the attractive condition. With three conditions, there would be six different orders (ABC, ACB, BAC, BCA, CAB, and CBA), so some participants would be tested in each of the six orders. With counterbalancing, participants are assigned to orders randomly, using the techniques we have already discussed. Thus random assignment plays an important role in within-subjects designs just as in between-subjects designs. Here, instead of randomly assigning to conditions, they are randomly assigned to different orders of conditions. In fact, it can safely be said that if a study does not involve random assignment in one form or another, it is not an experiment.

An efficient way of counterbalancing is through a Latin square design which randomizes through having equal rows and columns. For example, if you have four treatments, you must have four versions. Like a Sudoku puzzle, no treatment can repeat in a row or column. For four versions of four treatments, the Latin square design would look like:

There are two ways to think about what counterbalancing accomplishes. One is that it controls the order of conditions so that it is no longer a confounding variable. Instead of the attractive condition always being first and the unattractive condition always being second, the attractive condition comes first for some participants and second for others. Likewise, the unattractive condition comes first for some participants and second for others. Thus any overall difference in the dependent variable between the two conditions cannot have been caused by the order of conditions. A second way to think about what counterbalancing accomplishes is that if there are carryover effects, it makes it possible to detect them. One can analyze the data separately for each order to see whether it had an effect.

When 9 is “larger” than 221

Researcher Michael Birnbaum has argued that the lack of context provided by between-subjects designs is often a bigger problem than the context effects created by within-subjects designs. To demonstrate this problem, he asked participants to rate two numbers on how large they were on a scale of 1-to-10 where 1 was “very very small” and 10 was “very very large”.  One group of participants were asked to rate the number 9 and another group was asked to rate the number 221 (Birnbaum, 1999) [4] . Participants in this between-subjects design gave the number 9 a mean rating of 5.13 and the number 221 a mean rating of 3.10. In other words, they rated 9 as larger than 221! According to Birnbaum, this difference is because participants spontaneously compared 9 with other one-digit numbers (in which case it is relatively large) and compared 221 with other three-digit numbers (in which case it is relatively small) .

Simultaneous Within-Subjects Designs

So far, we have discussed an approach to within-subjects designs in which participants are tested in one condition at a time. There is another approach, however, that is often used when participants make multiple responses in each condition. Imagine, for example, that participants judge the guilt of 10 attractive defendants and 10 unattractive defendants. Instead of having people make judgments about all 10 defendants of one type followed by all 10 defendants of the other type, the researcher could present all 20 defendants in a sequence that mixed the two types. The researcher could then compute each participant’s mean rating for each type of defendant. Or imagine an experiment designed to see whether people with social anxiety disorder remember negative adjectives (e.g., “stupid,” “incompetent”) better than positive ones (e.g., “happy,” “productive”). The researcher could have participants study a single list that includes both kinds of words and then have them try to recall as many words as possible. The researcher could then count the number of each type of word that was recalled. There are many ways to determine the order in which the stimuli are presented, but one common way is to generate a different random order for each participant.

Between-Subjects or Within-Subjects?

Almost every experiment can be conducted using either a between-subjects design or a within-subjects design. This possibility means that researchers must choose between the two approaches based on their relative merits for the particular situation.

Between-subjects experiments have the advantage of being conceptually simpler and requiring less testing time per participant. They also avoid carryover effects without the need for counterbalancing. Within-subjects experiments have the advantage of controlling extraneous participant variables, which generally reduces noise in the data and makes it easier to detect a relationship between the independent and dependent variables.

A good rule of thumb, then, is that if it is possible to conduct a within-subjects experiment (with proper counterbalancing) in the time that is available per participant—and you have no serious concerns about carryover effects—this design is probably the best option. If a within-subjects design would be difficult or impossible to carry out, then you should consider a between-subjects design instead. For example, if you were testing participants in a doctor’s waiting room or shoppers in line at a grocery store, you might not have enough time to test each participant in all conditions and therefore would opt for a between-subjects design. Or imagine you were trying to reduce people’s level of prejudice by having them interact with someone of another race. A within-subjects design with counterbalancing would require testing some participants in the treatment condition first and then in a control condition. But if the treatment works and reduces people’s level of prejudice, then they would no longer be suitable for testing in the control condition. This difficulty is true for many designs that involve a treatment meant to produce long-term change in participants’ behaviour (e.g., studies testing the effectiveness of psychotherapy). Clearly, a between-subjects design would be necessary here.

Remember also that using one type of design does not preclude using the other type in a different study. There is no reason that a researcher could not use both a between-subjects design and a within-subjects design to answer the same research question. In fact, professional researchers often take exactly this type of mixed methods approach.

Key Takeaways

• Experiments can be conducted using either between-subjects or within-subjects designs. Deciding which to use in a particular situation requires careful consideration of the pros and cons of each approach.
• Random assignment to conditions in between-subjects experiments or to orders of conditions in within-subjects experiments is a fundamental element of experimental research. Its purpose is to control extraneous variables so that they do not become confounding variables.
• Experimental research on the effectiveness of a treatment requires both a treatment condition and a control condition, which can be a no-treatment control condition, a placebo control condition, or a waitlist control condition. Experimental treatments can also be compared with the best available alternative.
• You want to test the relative effectiveness of two training programs for running a marathon.
• Using photographs of people as stimuli, you want to see if smiling people are perceived as more intelligent than people who are not smiling.
• In a field experiment, you want to see if the way a panhandler is dressed (neatly vs. sloppily) affects whether or not passersby give him any money.
• You want to see if concrete nouns (e.g.,  dog ) are recalled better than abstract nouns (e.g.,  truth ).
• Discussion: Imagine that an experiment shows that participants who receive psychodynamic therapy for a dog phobia improve more than participants in a no-treatment control group. Explain a fundamental problem with this research design and at least two ways that it might be corrected.
• Price, D. D., Finniss, D. G., & Benedetti, F. (2008). A comprehensive review of the placebo effect: Recent advances and current thought. Annual Review of Psychology, 59 , 565–590. ↵
• Shapiro, A. K., & Shapiro, E. (1999). The powerful placebo: From ancient priest to modern physician . Baltimore, MD: Johns Hopkins University Press. ↵
• Moseley, J. B., O’Malley, K., Petersen, N. J., Menke, T. J., Brody, B. A., Kuykendall, D. H., … Wray, N. P. (2002). A controlled trial of arthroscopic surgery for osteoarthritis of the knee. The New England Journal of Medicine, 347 , 81–88. ↵
• Birnbaum, M.H. (1999). How to show that 9>221: Collect judgments in a between-subjects design. Psychological Methods, 4(3), 243-249. ↵

An experiment in which each participant is only tested in one condition.

A method of controlling extraneous variables across conditions by using a random process to decide which participants will be tested in the different conditions.

All the conditions of an experiment occur once in the sequence before any of them is repeated.

Any intervention meant to change people’s behaviour for the better.

A condition in a study where participants receive treatment.

A condition in a study that the other condition is compared to. This group does not receive the treatment or intervention that the other conditions do.

A type of experiment to research the effectiveness of psychotherapies and medical treatments.

A type of control condition in which participants receive no treatment.

A simulated treatment that lacks any active ingredient or element that should make it effective.

A positive effect of a treatment that lacks any active ingredient or element to make it effective.

Participants receive a placebo that looks like the treatment but lacks the active ingredient or element thought to be responsible for the treatment’s effectiveness.

Participants are told that they will receive the treatment but must wait until the participants in the treatment condition have already received it.

Each participant is tested under all conditions.

An effect of being tested in one condition on participants’ behaviour in later conditions.

Participants perform a task better in later conditions because they have had a chance to practice it.

Participants perform a task worse in later conditions because they become tired or bored.

Being tested in one condition can also change how participants perceive stimuli or interpret their task in later conditions.

Testing different participants in different orders.

Research Methods in Psychology - 2nd Canadian Edition Copyright © 2015 by Paul C. Price, Rajiv Jhangiani, & I-Chant A. Chiang is licensed under a Creative Commons Attribution-NonCommercial-ShareAlike 4.0 International License , except where otherwise noted.

Share This Book

User Preferences

Content preview.

Arcu felis bibendum ut tristique et egestas quis:

• Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris
• Duis aute irure dolor in reprehenderit in voluptate
• Excepteur sint occaecat cupidatat non proident

Keyboard Shortcuts

3.3 - experimental design terminology.

In experimental design terminology, the " experimental unit " is randomized to the treatment regimen and receives the treatment directly. The " observational unit " has measurements taken on it. In most clinical trials, the experimental units and the observational units are one and the same, namely, the individual patient

One exception to this is a community intervention trial in which communities, e.g., geographic regions, are randomized to treatments. For example, communities (experimental units) might be randomized to receive different formulations of a vaccine, whereas the effects are measured directly on the subjects (observational units) within the communities. The advantages here are strictly logistical - it is simply easier to implement in this fashion. Another example occurs in reproductive toxicology experiments in which female rodents are exposed to a treatment (experimental units) but measurements are taken on the pups (observational units).

In experimental design terminology, factors are variables that are controlled and varied during the course of the experiment. For example, treatment is a factor in a clinical trial with experimental units randomized to treatment. Another example is pressure and temperature as factors in a chemical experiment.

Most clinical trials are structured as one-way designs , i.e., only one factor, treatment, with a few levels.

Temperature and pressure in the chemical experiment are two factors that comprise a two-way design in which it is of interest to examine various combinations of temperature and pressure. Some clinical trials may have a two-way factorial design , such as in oncology where various combinations of doses of two chemotherapeutic agents comprise the treatments. An incomplete factorial design may be useful if it is inappropriate to assign subjects to some of the possible treatment combinations, such as no treatment (double placebo). We will study factorial designs in a later lesson.

A parallel design refers to a study in which patients are randomized to a treatment and remain on that treatment throughout the course of the trial. This is a typical design. In contrast, with a crossover design patients are randomized to a sequence of treatments and they cross over from one treatment to another during the course of the trial. Each treatment occurs in a time period with a washout period in between. Crossover designs are of interest since with each patient serving as their own control, there is potential for reduced variability. However, there are potential problems with this type of design. There should be investigation into possible carry-over effects, i.e. the residual effects of the previous treatment affecting subject’s response in the later treatment period. In addition, only conditions that are likely to be similar in both treatment periods are amenable to crossover designs. Acute health problems that do not recur are not well-suited for a crossover study. We will study crossover design in a later lesson.

Randomization is used to remove systematic error (bias) and to justify Type I error probabilities in experiments. Randomization is recognized as an essential feature of clinical trials for removing selection bias.

Selection bias occurs when a physician decides treatment assignment and systematically selects a certain type of patient for a particular treatment.. Suppose the trial consists of an experimental therapy and a placebo. If the physician assigns healthier patients to the experimental therapy and the less healthy patients to the placebo, the study could result in an invalid conclusion that the experimental therapy is very effective.

Blocking and stratification are used to control unwanted variation. For example, suppose a clinical trial is structured to compare treatments A and B in patients between the ages of 18 and 65. Suppose that the younger patients tend to be healthier. It would be prudent to account for this in the design by stratifying with respect to age. One way to achieve this is to construct age groups of 18-30, 31-50, and 51-65 and to randomize patients to treatment within each age group.

It is not necessary to have the same number of patients within each age stratum. We do, however, want to have a balance in the number on each treatment within each age group. This is accomplished by blocking, in this case, within the age strata. Blocking is a restriction of the randomization process that results a balance of numbers of patients on each treatment after a prescribed number of randomizations. For example, blocks of 4 within these age strata would mean that after 4, 8, 12, etc. patients in a particular age group had entered the study, the numbers assigned to each treatment within that stratum would be equal.

If the numbers are large enough within a stratum, a planned subgroup analysis may be performed. In the example, the smaller numbers of patients in the upper and lower age groups would require care in the analyses of these sub-groups specifically. However, with the primary question as to the effect of treatment regardless of age, the pooled data in which each sub-group is represented in a balanced fashion would be utilized for the main analysis.

Even ineffective treatments can appear beneficial in some patients. This may be due to random fluctuations, or variability in the disease. If, however, the improvement is due to the patient’s expectation of a positive response, this is called a " placebo effect ". This is especially problematic when the outcome is subjective, such as pain or symptom assessment. The placebo effect is widely recognized and must be removed in any clinical trial. For example, rather than constructing a nonrandomized trial in which all patients receive an experimental therapy, it is better to randomize patients to receive either the experimental therapy or a placebo. A true placebo is an inert or inactive treatment that mimics the route of administration of the real treatment, e.g., a sugar pill.

Placebos are not acceptable ethically in many situations, e.g., in surgical trials. (Although there have been instances where 'sham' surgical procedures took place as the 'placebo' control.) When an accepted treatment already exists for a serious illness such as cancer, the control must be an active treatment. In other situations, a true placebo is not physically possible to attain. For example, a few trials investigating dimethyl sulfoxide (DMSO) for providing muscle pain relief were conducted in the 1970’s and 1980’s. DMSO is rubbed onto the area of muscle pain but leaves a garlicky taste in the mouth, so it was difficult to develop a placebo.

Treatment masking or blinding is an effective way to ensure objectivity of the person measuring the outcome variables. Masking is especially important when the measurements are subjective or based on self-assessment. Double-masked trials refer to studies in which both investigators and patients are masked to the treatment. Single-masked trials refer to the situation when only patients are masked. In some studies, statisticians are masked to treatment assignment when performing the initial statistical analyses, i.e., not knowing which group received the treatment and which is the control until analyses have been completed. Even a safety-monitoring committee may be masked to the identity of treatment A or B, until there is an observed trend or difference that should evoke a response from the monitors. In executing a masked trial great care will be taken to keep the treatment allocation schedule securely hidden from all except those with a need to know which medications are active and which are placebo. This could be limited to the producers of the study medications, and possibly the safety monitoring board before study completion. There is always a caveat for breaking the blind for a particular patient in an emergency situation.

As with placebos, masking, although highly desirable, is not always possible. For example, one could not mask a surgeon to the procedure he is to perform. Even so, some have gone to great lengths to achieve masking. For example, a few trials with cardiac pacemakers have consisted of every eligible patient undergoing a surgical procedure to be implanted with the device. The device was "turned on" in patients randomized to the treatment group and "turned off" in patients randomized to the control group. The surgeon was not aware of which devices would be activated.

Investigators often underestimate the importance of masking as a design feature. This is because they believe that biases are small in relation to the magnitude of the treatment effects (when the converse usually is true), or that they can compensate for their prejudice and subjectivity.

Confounding is the effect of other relevant factors on the outcome that may be incorrectly attributed to the difference between study groups.

Here is an example: An investigator plans to assign 10 patients to treatment and 10 patients to control. There will be a one-week follow-up on each patient. The first 10 patients will be assigned treatment on March 01 and the next 10 patients will be assigned control on March 15. The investigator may observe a significant difference between treatment and control, but is it due to different environmental conditions between early March and mid-March? The obvious way to correct this would be to randomize 5 patients to treatment and 5 patients to control on March 01, followed by another 5 patients to treatment and the 5 patients to control on March 15.

Validity Section  

A trial is said to possess internal validity if the observed difference in outcome between the study groups is real and not due to bias, chance, or confounding. Randomized, placebo-controlled, double-blinded clinical trials have high levels of internal validity.

External validity in a human trial refers to how well study results can be generalized to a broader population. External validity is irrelevant if internal validity is low. External validity in randomized clinical trials is enhanced by using broad eligibility criteria when recruiting patients .

Large simple and pragmatic trials emphasize external validity. A large simple trial attempts to discover small advantages of a treatment that is expected to be used in a large population. Large numbers of subjects are enrolled in a study with simplified design and management. There is an implicit assumption that the treatment effect is similar for all subjects with the simplified data collection. In a similar vein, a pragmatic trial emphasizes the effect of a treatment in practices outside academic medical centers and involves a broad range of clinical practices.

Studies of equivalency and noninferiority have different objectives than the usual trial which is designed to demonstrate superiority of a new treatment to a control. A study to demonstrate non-inferiority aims to show that a new treatment is not worse than an accepted treatment in terms of the primary response variable by more than a pre-specified margin. A study to demonstrate equivalence has the objective of demonstrating the response to the new treatment is within a prespecified margin in both directions. We will learn more about these studies when we explore sample size calculations.